ABGII. MODULAR STEM Adverse Event — Injury (MDR 0002249697-2020-00825)
ABGII. MODULAR STEM Adverse Event — Injury (MDR 0002249697-2020-00825) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ABGII. MODULAR STEM; Generic name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYM; Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH.
| Device | ABGII. MODULAR STEM |
|---|---|
| Generic name | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYM |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Report number | 0002249697-2020-00825 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, OTHER |
| Narrative | REPORTED EVENT: AN EVENT REGARDING REVISION DUE TO PSEUDOTUMORAL MASS INVOLVING A ABGII MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DI |
| Source | openFDA MAUDE (device adverse events) |
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