FDA Adverse Event
Injury
Summary report: N
ORTHOMET(R) COBALT CHROME FEMORAL HEAD
MDR report key: 1850592
·
Received October 1, 2010
Report
- Report Number
- 1043534-2010-00401
- Event Type
- Injury
- Date Received
- October 1, 2010
- Date of Event
- August 19, 2010
- Report Date
- May 2, 2011
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDI
- PMA / PMN Number
- K880461
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ATTEMPTS ARE BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. TRENDS WILL BE EVAULATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGAITON IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00400. THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
CONCLUSION: NORMAL WEAR. 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 AFTER 13 YEARS OF IMPLANTATION, THIS COMPONENT IS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.
Description of Event or Problem · 1
ALLEGEDLY AFTER 13 YEARS OF IMPLANTATION, THIS COMPONENT IS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOMET(R) COBALT CHROME FEMORAL HEAD | HIP COMPONENT | JDI | WRIGHT MEDICAL TECHNOLOGY, INC. | 027A058204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |