| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 36MM VIT E LINER +6MM | PROSTHESIS, SHOULDER | ZIMMER BIOMET, INC. | PAO | N/A | 00435003606 | 63334004 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-11 | 0 |
Patient 1
(B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001822565 - 2018 - 07055. (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.
Patient 1
IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE POLY FAILED TO SEAT FULLY AND A SMALL PIECE OF POLY WAS SHAVED OFF THE LINER ATTEMPTING TO GET IT FULLY SEATED. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE MALFUNCTION. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.
Patient 1
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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.
Patient 1
NO FURTHER INFORMATION AVAILABLE AT THIS TIME.