FDA Adverse Event
Injury
Summary report: N
ADVANCE TOT COND MEDIAL PIVOT TIBIAL INSERT
MDR report key: 1052785
·
Received May 20, 2008
Report
- Report Number
- 1043534-2008-00106
- Event Type
- Injury
- Date Received
- May 20, 2008
- Date of Event
- March 12, 2008
- Report Date
- May 14, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HSH
- PMA / PMN Number
- K972770
- 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. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY REVISED TO A 12MM INSERT. PATIENT WAS HAVING A PATELLA TRACKING PROBLEM. WHILE THERE, INSERT CHANGED OUT. MINIMAL WEAR SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE TOT COND MEDIAL PIVOT TIBIAL INSERT | HSH | WRIGHT MEDICAL TECHNOLOGY, INC. | 039A100643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |