PROFEMUR® TL STEM SZ 6
Report
- Report Number
- 3010536692-2021-00618
- Event Type
- Injury
- Date Received
- December 31, 2021
- Report Date
- March 2, 2022
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JDI
- UDI-DI
- M684PRTL00261
- PMA / PMN Number
- K060358
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
ALLEGEDLY, FOLLOWING COMPLAINTS OF PAIN AND PHYSICAL LIMITATIONS, PATIENT REPORTED FOR REVISION SURGERY OF HIS LEFT HIP PROTHESIS. PATIENT´S REVISION SURGERY WAS NECESSARY DUE TO PAIN CAUSED BY A FAILED METAL ON METAL JUNCTION CORROSION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE COURSE OF THE REVISION SURGERY THE SURGEON REMOVED PATIENT?S WRIGHT MEDICAL HIP COMPONENTS, INCLUDING THE MODULAR NECK AND STEM.
ALLEGEDLY, FOLLOWING COMPLAINTS OF PAIN AND PHYSICAL LIMITATIONS, PATIENT REPORTED FOR REVISION SURGERY OF HIS LEFT HIP PROTHESIS. PATIENT´S REVISION SURGERY WAS NECESSARY DUE TO PAIN CAUSED BY A FAILED METAL ON METAL JUNCTION CORROSION ISSUE AT THE COCR MODULAR NECK AND TITANIUM STEM. IN THE COURSE OF THE REVISION SURGERY THE SURGEON REMOVED PATIENT?S WRIGHT MEDICAL HIP COMPONENTS, INCLUDING THE MODULAR NECK AND STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2026708 | PROFEMUR® TL STEM SZ 6 | HIP COMPONENT | JDI | MICROPORT ORTHOPEDICS INC. | PRTL0026 | 0101006408 | M684PRTL00261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |