E-POLY 32MM +3 MAXROM LNR SZ22

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 106022, LOCKING RING, LOT # 666530. ITEM # 16-104146, CUP, LOT # 640690. ITEM # XL-108222, LINER, LOT # 696150. ITEM # 103531, BONE SCREW, LOT # 063030. ITEM # 103533, BONE SCREW, LOT # 064250. ITEM # 163667, FEMORAL HEAD, LOT # 824420. ITEM # 51-108080, FEMORAL STEM, LOT # 3275307. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03932, 0001825034-2018-03934, 0001825034-2018-03935.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, A CUP WAS IMPLANTED. THE SURGEON WAS UNABLE TO GET MULTIPLE LINERS TO SEAT IN THE IMPLANTED CUP. AN ATTEMPT WAS MADE USING AN ALTERNATE LOCKING RING, WHICH WAS ALSO UNSUCCESSFUL. ALL ACETABULAR COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT. THE DEVICE MALFUNCTION CAUSED A SURGICAL DELAY OF ONE HOUR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.