E-POLY 36MM +3 HIWALL LNR SZ23

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OFT HE LINER SHOWED THAT IT WAS FRACTURED INTO SIX PIECES. BLACK DEBRIS WAS IDENTIFIED ON THE SURFACE OF THE LINER AS WELL AS IN THE BACK OF THE LINER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORT SOURCE: LEGAL NOTIFICATION. REPORTED EVENT WAS CONFIRMED DUE TO MEDICAL RECORDS RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07952, 0001825034-2017-07953, 0001825034-2017-07954, 0001825034-2018-02791.

Additional Manufacturer Narrative

REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE REMAINS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED 3 YEARS POST IMPLANTATION DUE TO GROSS METALLOSIS THROUGHOUT THE SOFT TISSUES EMANATING FROM THE HIP TO THE LEVEL OF THE SKIN WITH MULTIPLE FRACTURED POLYETHYLENE LINER FRAGMENTS AS WELL AS COMPLETE PROTRUSION OF THE CERAMIC FEMORAL HEAD WITH 3 ACETABULAR COMPONENTS WITH SIGNIFICANT METAL STAINING OF THE FEMORAL HEAD, ASYMMETRIC LOCATION OF THE FEMORAL HEAD WITH SOFT TISSUE SWELLING CONCERNING FOR FAILURE OF THE ACETABULAR POLYETHYLENE LINER WITH SUBSEQUENT GENERATION OF METAL DEBRIS. THERE WAS NOTED TO BE BLACKENED STAINING AROUND THE PROXIMAL ASPECT OF THE FEMORAL COMPONENT. NO POLYETHYLENE LINER REMAINING. THERE WAS COMPLETE WEAR SUPERIORLY THROUGH THE ACETABULAR SHELL. PATIENT WAS REVISED TO A COMPETITOR PRODUCT.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED 3 YEARS POST IMPLANTATION DUE TO GROSS METALLOSIS THROUGHOUT THE SOFT TISSUES EMANATING FROM THE HIP TO THE LEVEL OF THE SKIN WITH MULTIPLE FRACTURED POLYETHYLENE LINER FRAGMENTS AS WELL AS COMPLETE PROTRUSION OF THE CERAMIC FEMORAL HEAD WITH 3 ACETABULAR COMPONENTS WITH SIGNIFICANT METAL STAINING OF THE FEMORAL HEAD, ASYMMETRIC LOCATION OF THE FEMORAL HEAD WITH SOFT TISSUE SWELLING CONCERNING FOR FAILURE OF THE ACETABULAR POLYETHYLENE LINER WITH SUBSEQUENT GENERATION OF METAL DEBRIS. THERE WAS NOTED TO BE BLACKENED STAINING AROUND THE PROXIMAL ASPECT OF THE FEMORAL COMPONENT. NO POLYETHYLENE LINER REMAINING. THERE WAS COMPLETE WEAR SUPERIORLY THROUGH THE ACETABULAR SHELL.

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 11-106052, R/B RLOC LHOLE SHL 52MM SZ 23, 394190; 650-1057, CER BIOLOXD OPTION HD 36MM, 411390; 11-103203, TAPERLOC POR LAT FMRL 9X137, 172200; 650-1064, CER OPTION TYPE 1 TPR SLEVE -6, 231850. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07952, 0001825034 - 2017 - 07954. PRODUCT LOCATION UNKNOWN.

Description of Event or Problem

IT IS REPORTED BY THE PATIENT'S LEGAL COUNSEL THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ALLEGATIONS OF METALLOSIS, METAL DEBRIS, AND ASYMMETRIC LOCATION OF THE FEMORAL HEAD WITH SOFT TISSUE SWELLING. IT IS ALSO REPORTED THAT THE PATIENT'S HIP HAD SHATTERED INTO MULTIPLE FRAGMENTS, AND THE HEAD WAS SIGNIFICANTLY OUT OF PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

Additional Manufacturer Narrative

REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.