REFOBACIN BONE CEMENT R 2X40G

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS PLANNING TO BE REVISED DUE TO PAIN, SWELLING, INSTABILITY, REDUCED MOBILITY, AND ASEPTIC TIBIAL LOOSENING AS INDICATED ON BONE SCAN. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: ITEM NUMBER# 00598003702; STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 FOR CEMENTED USE ONLY USE OF THIS TIBIAL COMPONENT WITH LCCK ARTICULATING SURFACES REQUIRES USING A STEM EXTEN; LOT NUMBER# 63535344. ITEM NUMBER# 00596401552; FEMORAL COMPONENT OPTION SIZE E RIGHT COMPATIBLE WITH LPS-FLEX PROLONG; LOT NUMBER# 63118997. ITEM NUMBER# 40596009900; TAPER PLUG UNF; LOT NUMBER# 63558546. ITEM NUMBER# 00596403212; ARTICULAR SURFACE SIZE EF 12 MM HEIGHT ''USE WITH PLATE 3; LOT NUMBER# 64428181. ITEM NUMBER# 00597206532; ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS; LOT NUMBER# 64530937. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172408. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, B6, B7, G3, G6, H2, H11. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WITHOUT PATELLAR RESURFACING. THE PATIENT THEN UNDERWENT A POLY EXCHANGE AND PATELLAR RESURFACING APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION DUE TO PAIN AND OSTEOARTHRITIS PROGRESSION. SUBSEQUENTLY, THE PATIENT REPORTS SHE ANTICIPATES A SECOND REVISION LATER THIS YEAR DUE TO PAIN, SWELLING, INSTABILITY, REDUCED MOBILITY, AND ASEPTIC TIBIAL LOOSENING AS INDICATED ON BONE SCAN. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B2, B3, B4, B5, D6, E1, E2, E3, G2, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D2. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REPORTED CEMENT WAS REVIEWED FOR COMPATIBILITY WITH THE TIBIAL COMPONENT WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED OSTEOPOROTIC BONE AROUND FEMUR AND TIBIA AS CONTRIBUTING FACTOR OF EVENT. ON THE OPERATIONAL NOTES DATED TWO YEARS AND THREE MONTHS FROM THE INITIAL SURGERY, IT WAS FOUND THAT FEMORAL AND TIBIAL IMPLANTS WERE WELL FIXED, ONLY THE BEARING WAS EXCHANGED. ON THE FOLLOW-UP VISIT APPROXIMATELY TWO MONTHS LATER, INCISION WAS WELL HEALED, PATIENT HAS FULL RANGE OF MOTION, MILD PAIN, NO INSTABILITY AND NO CONCERNS WAS FOUND ON THE X-RAY. APPROXIMATELY SEVEN YEARS AND ELEVEN MONTHS POST THE INITIAL SURGERY, THE CT SCAN DEMONSTRATED INCREASED UPTAKE ALONG THE MEDIAL AND POSTERIOR ASPECTS OF THE SHAFT AS WELL AS THE TIP OF THE TIBIAL COMPONENT OF THE RIGHT KNEE PROSTHESIS. ON THE DAY OF THE REVISION, THE PATIENT STATES THAT SHE HAS HAD PAIN IN THAT TOTAL KNEE ARTHROPLASTY SINCE THE DAY IT WAS PUT IN. PAIN WAS LOCATED TO TIBIA. SHE HAD A BONE SCAN INDICATED TIBIA LOOSENING. CEMENT MANTLE WAS FOUND DISRUPTED WITH OSTEOTOMES, TIBIAL AND FEMORAL COMPONENTS WERE REMOVED WITHOUT COMPLICATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY WITHOUT PATELLAR RESURFACING. THE PATIENT UNDERWENT A POLY EXCHANGE AND PATELLAR RESURFACING TWO YEARS AND THREE MONTHS POST IMPLANTATION DUE TO PAIN AND OSTEOARTHRITIS PROGRESSION. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY EIGHT YEARS AND THREE MONTHS POST INITIAL IMPLANTATION DUE TO PAIN, SWELLING, INSTABILITY, REDUCED MOBILITY, AND ASEPTIC TIBIAL LOOSENING AS INDICATED ON BONE SCAN. THE PATELLAR IMPLANT WAS RETAINED WHILE ALL TIBIAL AND FEMORAL COMPONENTS WERE REVISED WITHOUT COMPLICATION. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.