MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-09 for DEPUY * D2360-71 manufactured by Depuy.
[28362]
The cup inserter was screwed into the acetabular shell cup as part of the procedure to force the cup into the acetabulum. The cup inserter may have stripped the threads of the hole, thus causing misalignment of the apex hole eliminator into the shell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 44413 |
| MDR Report Key | 44413 |
| Date Received | 1996-10-09 |
| Date of Report | 1996-09-09 |
| Date of Event | 1996-07-29 |
| Date Facility Aware | 1996-07-29 |
| Report Date | 1996-09-09 |
| Date Reported to Mfgr | 1996-09-09 |
| Date Added to Maude | 1996-10-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPUY |
| Generic Name | CUP INSERTER |
| Product Code | HXO |
| Date Received | 1996-10-09 |
| Model Number | * |
| Catalog Number | D2360-71 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 45337 |
| Manufacturer | DEPUY |
| Manufacturer Address | 700 ORTHOPAEDIC DR WARSAW IN 46581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-09 |