FDA Adverse Event
Malfunction
Summary report: N
GLENOID-DE PUY
MDR report key: 173777
·
Received June 15, 1998
Report
- Report Number
- MW1014042
- Event Type
- Malfunction
- Date Received
- June 15, 1998
- Date of Event
- April 28, 1998
- Report Date
- June 11, 1998
- Manufacturer
- DEPUY, INC.
- Product Code
- KYM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLENOID-DE PUY Implant | GLENOID COMPONENT | KYM | DEPUY, INC. | PEGGED GLENOID | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |