TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM Adverse Event — Malfunction (MDR 0001825034-2020-01804)
TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM Adverse Event — Malfunction (MDR 0001825034-2020-01804) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM; Generic name: PROSTHESIS, HIP; Manufacturer: ZIMMER BIOMET
| Device | TAPERLOC COMPLETE XR 123 MICRO FEMORAL POROUS COATED STEM |
|---|---|
| Generic name | PROSTHESIS, HIP |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001825034-2020-01804 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; D11; G4; H2; H3; H4; H6 COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. SIX BOXES WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE RETURNED BOXES HAVE LOOSE WHITE DEBRIS INSIDE OF THE CLEAR PLASTIC PACKAGING. THE STERILE BARRIER IS INTA |
| Source | openFDA MAUDE (device adverse events) |
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