TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 13 MM THICKNESS Adverse Event — Malfunction (MDR 0001822565-2020-01524)
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 13 MM THICKNESS Adverse Event — Malfunction (MDR 0001822565-2020-01524) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 13 MM THICKNESS; Generic name: PROSTHESIS, KNEE; Manufactur
| Device | TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 13 MM THICKNESS |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01524 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G4, G7, H2, H3, H6, H7, H9, H10. THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH PHYSICAL EVALUATION. THE RETURNED SHIM EXHIBITED SIGNS OF REPEATED USE (NICKED/GOUGED). ONE OF EACH OF THE SPRINGS AND BALL BEARINGS WAS DISSASSEMBLED AND NOT RETURNED FOR |
| Source | openFDA MAUDE (device adverse events) |
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