FDA Adverse Event
Injury
Summary report: N
PROFEMUR(R) RENAISSANCE(R) STEM
MDR report key: 2143340
·
Received June 29, 2011
Report
- Report Number
- 1043534-2011-00299
- Event Type
- Injury
- Date Received
- June 29, 2011
- Date of Event
- May 20, 2011
- Report Date
- May 20, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- PMA / PMN Number
- K051995
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DEVICE #3: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00297, 00298, 00300, 00301.
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED; UNDETERMINED.
Description of Event or Problem · 1
ALLEGEDLY REMOVED DUE TO LOOSENESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFEMUR(R) RENAISSANCE(R) STEM | HIP COMPONENT | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 066347856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |