ATTUNE PS FB INSRT SZ 4 5MM Adverse Event — Malfunction (MDR 1818910-2020-11389)
ATTUNE PS FB INSRT SZ 4 5MM Adverse Event — Malfunction (MDR 1818910-2020-11389) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ATTUNE PS FB INSRT SZ 4 5MM; Generic name: ATTUNE IMPLANT : KNEE TIBIAL INSERT; Manufacturer: DEPUY IRELAND - 9616671.
| Device | ATTUNE PS FB INSRT SZ 4 5MM |
|---|---|
| Generic name | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Report number | 1818910-2020-11389 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | CONSUMER, OTHER |
| Narrative | PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION, HOWEVER, PHOTOS PROVIDED FOR REVIEW REVEALED POLYWEAR. NO EVIDENCE WAS FOUND OF PRODUCT ERROR AS A CONTRIBUTING FACTOR TO THE ABRASIVE WEAR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE |
| Source | openFDA MAUDE (device adverse events) |
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