TPRLC 133 T1 PPS HO 15X150MM 0MM T1 Adverse Event — Malfunction (MDR 0001825034-2020-01725)
TPRLC 133 T1 PPS HO 15X150MM 0MM T1 Adverse Event — Malfunction (MDR 0001825034-2020-01725) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TPRLC 133 T1 PPS HO 15X150MM 0MM T1; Generic name: PROSTHESIS, HIP; Manufacturer: ZIMMER BIOMET, INC..
| Device | TPRLC 133 T1 PPS HO 15X150MM 0MM T1 |
|---|---|
| Generic name | PROSTHESIS, HIP |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001825034-2020-01725 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: UDI#: (B)(4). THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D4, G4, G7, H2, H3, H4, H6, H10. EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE STERILE PACKAGING (BLISTER AND FOAM) IS DAMAGED AND THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FO |
| Source | openFDA MAUDE (device adverse events) |
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