CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 EF TOP Adverse Event — Malfunction (MDR 0001822565-2020-01535)
CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 EF TOP Adverse Event — Malfunction (MDR 0001822565-2020-01535) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 EF TOP; Generic name: PROSTHESIS, KNEE; Manufacturer: ZI
| Device | CPS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 EF TOP |
|---|---|
| Generic name | PROSTHESIS, KNEE |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001822565-2020-01535 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G4; G7; H1; H2; H3; H6 COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION EXHIBITS SIGNS OF REPEATED USE AND THE ANTERIOR OF THE POST FEATURE HAS FRACTURED OFF. DEVICE HISTORY RECORD (DHR) REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIA |
| Source | openFDA MAUDE (device adverse events) |
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