FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) Z STEM PLASMA SPRAYED
MDR report key: 1971222
·
Received January 26, 2011
Report
- Report Number
- 1043534-2011-00024
- Event Type
- Injury
- Date Received
- January 26, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 23, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K021346
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT.
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUTED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00023, 00025, 00026.
Description of Event or Problem · 1
ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) Z STEM PLASMA SPRAYED | HIP COMPONENT | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 026312022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R |