EXCEED ABT E1 MULLER CUP 36X58

Additional Manufacturer Narrative

(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: STANMORE COCR FMRL SZ2 STD, CATALOG #: 164242, LOT #: 3188790; MEDICAL PRODUCT: 36MM COCR MOD HD STD, CATALOG #: 11-363662, LOT #: 266170. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00270, 0001825034 -2019 -01089. 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.

Description of Event or Problem

HIP REVISION DUE TO DISLOCATION AND SUBLUXATION, MALALIGNED SOCKET AND MALALIGNED STEM.