ATTUNE PS RP INSRT SZ5 6MM Adverse Event — Injury (MDR 1818910-2020-11432)
ATTUNE PS RP INSRT SZ5 6MM Adverse Event — Injury (MDR 1818910-2020-11432) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ATTUNE PS RP INSRT SZ5 6MM; Generic name: ATTUNE IMPLANT : KNEE TIBIAL INSERT; Manufacturer: DEPUY IRELAND - 9616671.
| Device | ATTUNE PS RP INSRT SZ5 6MM |
|---|---|
| Generic name | ATTUNE IMPLANT : KNEE TIBIAL INSERT |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Report number | 1818910-2020-11432 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES |
| Source | openFDA MAUDE (device adverse events) |
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