INFINITY TOTAL ANKLE SYSTEM Adverse Event — Injury (MDR 1043534-2020-00086)
INFINITY TOTAL ANKLE SYSTEM Adverse Event — Injury (MDR 1043534-2020-00086) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INFINITY TOTAL ANKLE SYSTEM; Generic name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER; Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC..
| Device | INFINITY TOTAL ANKLE SYSTEM |
|---|---|
| Generic name | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Report number | 1043534-2020-00086 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 33650005, LOT 1623788; PART # 33630025, LOT 1594888; PART # 33655506, LOT 1590832. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. |
| Source | openFDA MAUDE (device adverse events) |
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