FDA Adverse Event
Injury
Summary report: N
GLOBAL ADVANTAGE HUM HD 44X18
MDR report key: 405456
·
Received July 18, 2002
Report
- Report Number
- 1818910-2002-00391
- Event Type
- Injury
- Date Received
- July 18, 2002
- Date of Event
- June 18, 2002
- Report Date
- July 18, 2002
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
WOULD NOT SEAT IN STEM #1134-08-000. SURGERY EXTENDED 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLOBAL ADVANTAGE HUM HD 44X18 | TOTAL SHOULDER PROSTHESIS | KWT | DEPUY ORTHOPAEDICS, INC. | NA | VF1CN1028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |