UNK HIP ACETABULAR CUP PINNACLE

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H3, H6: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

Description of Event or Problem

IT WAS REPORTED THAT IN 2016, PATIENT RECEIVED AN MRI OF BOTH HIPS, WHICH INDICATED THAT THE PATIENT REQUIRED TOTAL HIP REPLACEMENTS OF BOTH RIGHT AND LEFT HIPS. PRIOR TO ELECTING TO PROCEED WITH HIP SURGERY, PATIENT'S FAMILY INFORMED THE ATTENDING PHYSICIAN THAT PATIENT IS ALLERGIC TO METAL. THE ATTENDING PHYSICIAN RESPONDED BY SAYING "MOST PEOPLE DO NOT HAVE PROBLEMS WITH TITANIUM," WHICH PROMPTED PATIENT TO PROCEED WITH THE HIP SURGERY. THIS INTERCHANGE SUGGESTS THAT THE SURGEON DID NOT INTEND TO PLACE ANY COBALT-CHROME IMPLANTS, USING A CERAMIC FEMORAL HEAD AND A CERAMIC OR POLYETHYLENE ACETABULAR LINER INSTEAD. ON (B)(6) 2017, PATIENT UNDERWENT SURGERY FOR A RIGHT TOTAL HIP REPLACEMENT, WHERE THE DOCTOR SURGICALLY INSERTED A CERAMIC HEAD IN THE RIGHT HIP. THE MANUFACTURER AND IMPLANT PRODUCT INFORMATION WAS NOT PROVIDED FOR THE RIGHT HIP REPLACEMENT; IT IS NOT KNOWN IF THIS HIP WAS A DEPUY-MANUFACTURED HIP REPLACEMENT. IN (B)(6) 2017, PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY WHERE, DURING THE PROCEDURE, THE CERAMIC HEAD FRACTURED. IN PLACE OF THE CERAMIC HEAD, THE DOCTOR SURGICALLY INSERTED A COBALT CHROMIUM HEAD IN PATIENT'S LEFT HIP. AFTER THE PROCEDURE, PATIENT LEARNED THAT THE CERAMIC BALL HAD BROKEN DURING INSTALLATION AND THAT THE PROVIDERS HAD USED THE PHRS. THEREFORE, IT WAS STATED THAT THE PATIENT RECEIVED A LEFT TOTAL HIP REPLACEMENT CONSISTING OF A DEPUY TRI-LOCK FEMORAL STEM, DEPUY COBALT CHROMIUM FEMORAL HEAD, AND A DEPUY PINNACLE ACETABULAR CUP AND INSERT. THE LITIGATION IDENTIFIES THIS ENTIRE HIP CONSTRUCT AS PHRS (PINNACLE HIP REPLACEMENT SYSTEM) AND CLAIMS, "THE PHRS IS A 'METAL ON METAL' ARTIFICIAL HIP, DUE TO THE FACT THAT BOTH ARTICULATING SURFACES, THE FEMORAL HEAD (BALL), AND THE ACETABULUM LINER (SOCKET) ARE COMPRISED OF A COBALT-CHROMIUM ALLOY. THE PHRS COMPONENTS WERE FABRICATED WITH A COBALT-CHROMIUM ALLOY." THE OBVIOUS ISSUE WITH THIS CLAIM THAT THIS PATIENT'S HIP WAS A "METAL ON METAL" ARTIFICIAL HIP IS THAT DEPUY REMOVED THE PINNACLE METAL-ON-METAL CONSTRUCT FROM THE MARKET IN MAY 2013, MORE THAN FOUR YEARS PRIOR TO THE PATIENT RECEIVING HIS HIP REPLACEMENT IN (B)(6) 2017. SO, WHILE THE ACETABULAR CUP MAY HAVE BEEN PINNACLE, AND THE FEMORAL STEM TRI-LOCK, WITH A COBALT-CHROME METAL FEMORAL HEAD, THE ACETABULAR LINER COULD NOT HAVE BEEN A COBALT-CHROME METAL LINER. IN (B)(6) 2017, PATIENT BEGAN EXPERIENCING PROBLEMS, INCLUDING A METAL TASTE IN HIS MOUTH, WEAKNESS IN HIS LEGS, VERTIGO, AND VOMITING. AFTER THREE MONTHS OF CONSTANT VOMITING, PATIENT EXPERIENCED SIGNIFICANT WEIGHT CHANGE FROM TWO-HUNDRED-SEVENTY (270) POUNDS TO UNDER ONE-HUNDRED EIGHTY (180) POUNDS. PATIENT ALSO EXPERIENCED NAUSEA, WORSENING VISION, LOSS OF HEARING, MEMORY RETENTION PROBLEMS, DECREASING VITAMIN LEVELS, AND TREMORS, ALL OF WHICH BECAME PROGRESSIVELY WORSE. IN (B)(6) 2021, AFTER SEEING SEVERAL DOCTORS AND UNDERGOING VARYING MEDICAL EXAMINATIONS, ONE PHYSICIAN CONCLUDED THAT PATIENT WAS SHOWING SIGNS OF COBALT POISONING. IN (B)(6) 2022, FOLLOWING A PET SCAN, PATIENT WAS DIAGNOSED WITH HYDROCEPHALUS CAUSED BY COBALT POISONING/METAL TOXICITY. ON (B)(6) 2022, A PHYSICIAN PLACED A SHUNT IN PATIENT'S HEAD PRIOR TO THE HIP REVISION. AFTER THE SHUNT WAS PLACED, PATIENT BECAME COHERENT AND RESPONSIVE, INQUIRING WHY HE WAS IN THE HOSPITAL. ON (B)(6) 2022, THE ATTENDING PHYSICIAN PERFORMED THE LEFT HIP REVISION, WHERE THE COBALT-CHROME METAL FEMORAL HEAD WAS FOUND TO BE VISIBLY RUSTED AND PITTED. THIS WAS SUBSEQUENTLY REPLACED WITH A CERAMIC FEMORAL HEAD. THIS WAS FOLLOWED BY THREE YEARS OF PHYSICAL THERAPY. DURING THE INITIAL PERIOD OF THIS PHYSICAL THERAPY, ONE OF THE PATIENT'S ATTENDING CERTIFIED NURSE ASSISTANTS ("CNAS"), WHILE ATTEMPTING TO CHANGE HIS BED SHEETS AND CLOTHES, TWISTED THE LEFT LEG ON WHICH THE REVISION HAD BEEN CONDUCTED. AFTER THIS EVENT, THE PATIENT "DRAGGED THAT LEG." THE PATIENT WAS ABLE TO WALK DURING THAT PERIOD. ON (B)(6) 2024, PATIENT COMPLAINED THAT HE WAS UNABLE TO LIFT HIS LEGS. HE WAS ADMITTED TO THE HOSPITAL FOR TWO WEEKS. DOCTORS WERE NOT ABLE TO ACCURATELY DIAGNOSE PATIENT'S CONDITION. HE WAS DIAGNOSED AS PARAPLEGIC. NEUROLOGISTS COULD NOT MEDICALLY DIAGNOSE PATIENT AND PRESUMED THAT HE WAS STILL SUFFERING FROM METAL TOXICITY. IN 2025, PATIENT WAS TRANSFERRED TO ANOTHER PHYSICIAN, WHO RAN SEVERAL TOXICOLOGY TESTS AND STATED THAT PATIENT HAD BEEN POISONED BY SEVERAL DIFFERENT METALS: LEAD, CHROMIUM, COBALT, TITANIUM, GADOLINIUM POISONING FROM MRI CONTRAST, MERCURY, AND ARSENIC. FOLLOWING THIS DIAGNOSIS, PATIENT WAS RE-ADMITTED TO THE HOSPITAL BECAUSE OF HIGH CALCIUM LEVELS IN HIS BODY. FROM (B)(6) 2025, PATIENT WAS CONSTANTLY VOMITING DAILY, WHILE EXPERIENCING POSITIONAL VERTIGO, AND HE BECAME DEHYDRATED. IN (B)(6) 2025, PATIENT HAD ALL HIS TEETH EXTRACTED BECAUSE THEY WERE ALL INFECTED. IN ADDITION, DOCTORS FOUND THAT HE HAD KIDNEY STONES AND UNSPECIFIED INFECTIONS, WHICH WERE CAUSED BY THE METAL TOXICITY. IN (B)(6) 2026, PATIENT WAS DIAGNOSED WITH BLOOD CANCER THAT WAS A RESULT OF THE METALLOSIS. ON (B)(6) 2026, PATIENT DIED OF CONDITIONS RELATING TO THE COBALT AND CHROMIUM TOXICITY. IT IS POSSIBLE METAL ION TOXICITY MIGHT HAVE BEEN RELATED TO THE LEFT HIP HEAD-TRUNNION INTERACTION OF THE COBALT-CHROME FEMORAL HEAD AND THE TITANIUM ALLOY TRUNNION OF THE FEMORAL STEM. THERE WAS NO REASONABLE EVIDENCE OF A METAL ACETABULAR LINER IN THE KNOWN LEFT HIP. THE MANUFACTURER OF THE RIGHT TOTAL HIP PRODUCTS REMAINS UNKNOWN. RECORDS ONLY IDENTIFY REVISION OF THE LEFT HIP FEMORAL HEAD, REPLACING THE METAL HEAD WITH CERAMIC. DOI: (B)(6) 2017. DOE: (B)(6) 2017. DOR: (B)(6) 2022. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.