OXF TWIN-PEG CMNTD FEM MD PMA
Received Oct 25, 2018 · Event occurred Sep 25, 2018
Report 3002806535-2018-01159 · MDR key 8006250
Device
Product problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
Patient
61 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). MEDICAL PRODUCT - OXF UNI TIB TRAY SZ C RM PMA, ITEM 154723, LOT 061460. THERAPY DATE - (B)(6) 2018. MEDICAL PRODUCT - OXF ANAT BRG RT MD SIZE 3 PMA, ITEM 159575, LOT 657640. THERAPY DATE - (B)(6) 2018. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 3002806535-2018-01160 AND 3002806535-2018-01161.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING.
Additional Manufacturer Narrative
(B)(4). UDI: (B)(4). 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.