UNKNOWN POLY COMPONENT
Received Nov 30, 2018
Report 0001822565-2018-06667 · MDR key 8121113
Device
Generic name
Prosthesis, Extremity
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
NI
Lot number
NI
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). IMPLANTED IN 2002. EXPLANTED IN 2012. FOREIGN. THE EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TEN YEARS POST-IMPLANTATION FOR A POLY EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UPDATED: ADDITIONAL: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.