FDA Adverse Event
Injury
Summary report: N
RIM-LOCK
MDR report key: 12204385
·
Received July 21, 2021
Report
- Report Number
- 3010536692-2021-00403
- Event Type
- Injury
- Date Received
- July 21, 2021
- Date of Event
- June 29, 2021
- Report Date
- September 30, 2021
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY, THERE WAS ANTERIOR DISLOCATION POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1097997 | RIM-LOCK | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | PHA04660 | 1861506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |