FDA Adverse Event
Summary report: N
STRYKER ACETABULAR DOME HOLE PLUG
MDR report key: 2931792
·
Received December 27, 2012
Report
- Report Number
- 2931792
- Date Received
- December 27, 2012
- Date of Event
- July 23, 2012
- Report Date
- December 27, 2012
- Manufacturer
- STRYKER
- Product Code
- KWB
- Report Source
- User Facility report
- Reporter Location
- UT, US
Narratives
Description of Event or Problem · 1
PATIENT WAS ADMITTED WITH AN INFECTED RIGHT TOTAL HIP REPLACEMENT FROM 2010. THE PROSTHESIS WAS EXPLANTED. NOT A MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER ACETABULAR DOME HOLE PLUG | PROSTHESIS, HIP, ACETABULAR COMPONENT | KWB | STRYKER | * | 1JK0D0 | |
| 2 | STRYKER TRITANIUM | PROSTHESIS, HIP, HEMISPHERICAL CLUSTER HOLE SHELL | LPH | STRYKER | * | 502-03-56E | |
| 3 | STRYKER TRIDENT | PROSTHESIS, HIP, POLYETHYLENE INSERT | LZO | STRYKER | C3 0* POLYETHYLENE INSERT | 623-0040E | |
| 4 | REJUVENATE | PROSTHESIS, HIP, MODULAR NECK | MEH | STRYKER | NLV-340880Y | * | |
| 5 | STRYKER TORX | PROSTHESIS, HIP, CANCELLOUS BONE SCREW | HRS | STRYKER | * | MJMY05 | |
| 6 | STRYKER TORX | PROSTHESIS, HIP, CANCELLOUS BONE SCREW | HRS | STRYKER | * | MJLJDT | |
| 7 | REJUVENATE SPT MODULAR STEM | PROSTHESIS, HIP, MODULAR STEM | MEH | STRYKER | * | MJD7K1 | |
| 8 | STRYKER LFIT ANATOMIC V40 | PROSTHESIS, HIP, FEMORAL HEAD | LZO | STRYKER | * | MJL5H0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |