FDA Adverse Event
Injury
Summary report: N
TRANSCEND(R) QUADRANT SHELL
MDR report key: 923614
·
Received October 4, 2007
Report
- Report Number
- 1043534-2007-00163
- Event Type
- Injury
- Date Received
- October 4, 2007
- Date of Event
- September 7, 2007
- Report Date
- September 25, 2007
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-2007-00162, 00161.
Description of Event or Problem · 1
ALLEGEDLY, RECURRENT DISLOCATION. COMPONENT POSITION LOOKED UNCHANGED ON X-RAY. ON OPENING THE HIP, QUITE SEVERE METALLOSIS WAS FOUND. DECIDED TO REMOVE THE TRANSCEND CUP AND INSERTED A LINEAGE SHELL, CHANGING THE ORIENTATION SLIGHTLY. INSERTED A 15 DEG LATERALIZED +4MM LINER AND NSF 32MM +7MM HEAD TO GET SUITABLE STABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSCEND(R) QUADRANT SHELL | NONE | KWB | WRIGHT MEDICAL TECHNOLOGY, INC. | 107A0580333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R |