E-POLY 36MM +3 MAXROM LNR SZ23
Received Apr 13, 2020 · Event occurred Mar 4, 2020
Report 0001825034-2020-01611 · MDR key 9954169
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108223
Lot number
837090
Product problems
- Fracture
- Naturally Worn
- Fracture
- Naturally Worn
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL. X-RAYS REVEALED ANTERIOR EDGE WEAR ON THE POLY AND THE RETAINING RING WITHIN THE SHELL HAD FRACTURED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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.
Description of Event or Problem
IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO PAIN AND POLYETHYLENE WEAR . DURING THE REVISION, IT WAS NOTED THAT THE LOCKING RING WAS FRACTURED. THE LINER AND LOCKING RING WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: PT-116054-REGEN/RNGLC+ LTD 54MM SZ 23-893710, 650-1057-DELTA CERAMIC OPTION HEAD DIA3 6-811710, 650-1064-CER OPTION TYPE 1 TPR SLEVE -6 PE 1-938200, 51-106100-TPRLC 133 MP TYPE1 PPS SO 10.0 1-3730440, 103533-TI LOW PROFILE SCREW 6.5X30MM IA6.5X30MM-760590, 123741-3/8-24 APICAL HOLE PLUG 1/CUP-033860, 103532-BM ACET LP DOME SCW TI S/TAP D IA6.5X25MM-893710. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 01647. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO POLYETHYLENE WEAR. DURING THE PROCEDURE IT WAS NOTED THAT THE POLYETHYLENE AND LOCKING RING WERE BROKEN. A NEW POLYETHYLENE AND LOCKING RING WERE IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.