(B)(4). IMPLANT DATE UNKNOWN APPROXIMATELY 7 YEARS AGO. CONCOMITANT MEDICAL PRODUCTS: PART # 00781804600, ENDO FEMORAL HEAD, LOT # 61522149. REPORT SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OFFICE VISIT NOTES STATING PATIENT IS EXPERIENCING PAIN AND PSEUDOTUMOR. VISUAL INSPECTION OF THE RETURNED DEVICE NOTES DARK DEBRIS ON CONICAL TAPERS. THE HEAD TAPER SHOWS A THREAD LIKE PATTERN THAT COINCIDES WITH THE SURFACE OF THE STEM TAPER. MATERIAL ANALYSIS DETERMINED THAT THE MATERIAL OF NON-CORROSION REGION THE HEAD WAS CONFORMING. DHR WAS REVIEWED AND NO DISCREPANCIES THAT WOULD RELATE THE REPORTED EVENT WERE NOTED. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. A REPORT OF THE FINDINGS WAS SENT TO THE REPORTER. 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 MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2019 - 00724.
D
Patient 1
IT WAS REPORTED THAT PATIENT PRESENTED TO PHYSICIAN APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO PAIN. THE PATIENT HAD A NEGATIVE INFECTION WORKUP, AND RADIOLOGY SCAN POSITIVE FOR PSEUDOTUMOR. DURING THE SURGERY, BLACK DEBRIS AND TISSUE WAS NOTED AROUND THE NECK OF THE HIP STEM AND THE STEM COMPONENT WAS ABLE TO BE EASILY REMOVED WITH ONLY A FEW TAPS OF A MALLET. ALL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.