FDA Adverse Event
Injury
Summary report: N
GLOBAL SHD HYL FIN GLENOID 52
MDR report key: 384429
·
Received March 27, 2002
Report
- Report Number
- 1818910-2002-00164
- Event Type
- Injury
- Date Received
- March 27, 2002
- Date of Event
- September 24, 1997
- Report Date
- March 27, 2002
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS REVISED FOR HYLAMER WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLOBAL SHD HYL FIN GLENOID 52 | TOTAL SHOULDER PROSTESIS | KWS | DEPUY ORTHOPAEDICS, INC. | NA | 740300023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |