FDA Adverse Event
Injury
Summary report: N
DEPUY PROSTHESIS
MDR report key: 18609
·
Received August 2, 1994
Report
- Report Number
- 18609
- Event Type
- Injury
- Date Received
- August 2, 1994
- Date of Event
- March 31, 1994
- Report Date
- March 31, 1994
- Manufacturer
- DEPUY
- Product Code
- JDG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
S/P THA POLYETHELYNE FAILURE. PATIENT DIAGNOSED WITH RIGHT HIP PAIN. REVISION THA RT. 3/31/94.(D-6) PRODUCT MODEL # - CUP #1107-56-000 INSERT #1115-22-000 FEMORAL #1041-20-000 PRODUCT LOT # - CUP #896820019 INSERT #870360052 FEMORAL #664780005
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY PROSTHESIS Implant | CUP INSERT FEMORAL | JDG | DEPUY | SEE #5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |