MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-15 for GLENOID-DE PUY PEGGED GLENOID * manufactured by Depuy, Inc..
[121696]
Surface of glenoid fragmented. Pt with previous shoulder arthroplasty in jan 1996 for degenerative joint disease. Evidence suggesting upward displacement of humeral head relative to glenoid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014042 |
| MDR Report Key | 173777 |
| Date Received | 1998-06-15 |
| Date of Report | 1998-06-11 |
| Date of Event | 1998-04-28 |
| Date Added to Maude | 1998-06-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLENOID-DE PUY |
| Generic Name | GLENOID COMPONENT |
| Product Code | KYM |
| Date Received | 1998-06-15 |
| Model Number | PEGGED GLENOID |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 168957 |
| Manufacturer | DEPUY, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-06-15 |