ZT TRIAL SLEEVE 16D LRG Adverse Event — Malfunction (MDR 1818910-2020-11365)
ZT TRIAL SLEEVE 16D LRG Adverse Event — Malfunction (MDR 1818910-2020-11365) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ZT TRIAL SLEEVE 16D LRG; Generic name: HIP INSTRUMENTS : FEMORAL TRIALS; Manufacturer: DEPUY ORTHOPAEDICS INC US.
| Device | ZT TRIAL SLEEVE 16D LRG |
|---|---|
| Generic name | HIP INSTRUMENTS : FEMORAL TRIALS |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Report number | 1818910-2020-11365 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| 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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