FDA Adverse Event
Injury
Summary report: N
RIM-LOCK
MDR report key: 15199381
·
Received August 10, 2022
Report
- Report Number
- 3010536692-2022-00279
- Event Type
- Injury
- Date Received
- August 10, 2022
- Report Date
- October 13, 2022
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 0
ALLEGEDLY, PATIENT UNDERWENT LEFT THR ON (B)(6) 2022. REVISED ON (B)(6) 2022 DUE TO INFECTION. PERFORMED WASHOUT AND CHANGE OF LINER AND FEMORAL HEAD. SURGICAL SPECIALTIES REF (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1605196 | RIM-LOCK | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | PHA04664 | 1859470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Required Intervention |