FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) Z STEM PLASMA SPRAYED
MDR report key: 1891478
·
Received November 4, 2010
Report
- Report Number
- 1043534-2010-00453
- Event Type
- Injury
- Date Received
- November 4, 2010
- Date of Event
- October 7, 2010
- Report Date
- July 25, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K021346
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. NO COMPLAINT WAS STATED AGAINST THIS COMPLAINT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00452, 00454.
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED.EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ALLEGEDLY REMOVED DURING THE REVISION ON ANOTHER COMPONENT.
Description of Event or Problem · 1
ALLEGEDLY REMOVED DURING THE REVISION ON 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. | 046330494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |