UNKNOWN POLY COMPONENT
Received Nov 30, 2018 · Event occurred Oct 15, 2014
Report 0001822565-2018-06668 · MDR key 8121202
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
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.
Additional Manufacturer Narrative
(B)(4). FOREIGN. THE EVENT OCCURRED IN (B)(6). THE PATIENT WAS PRIMARILY IMPLANTED IN 2002 AND REVISED IN 2012 ON AN UNKNOWN DEVICE, UNKNOWN APPENDAGE, AND THIS DEVICE WAS REVISED ON (B)(6) 2014. THE INVESTIGATION IS IN PROCESS. 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 TO ADDRESS A POLY EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.