FDA Adverse Event
Injury
Summary report: N
RM52260045 DS10014522 BI MENTUM RK PE LINER 22 45
MDR report key: 21225999
·
Received January 23, 2025
Report
- Report Number
- 3008668801-2025-00037
- Event Type
- Injury
- Date Received
- January 23, 2025
- Date of Event
- April 6, 2023
- Report Date
- January 23, 2025
- Manufacturer
- S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION
- Product Code
- MEH
- UDI-DI
- 03662200015511
- PMA / PMN Number
- K181744
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 0
(B)(4): SERF RC-23-0080 PATIENT WAS REVISED DUE TO HIP DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858123 | RM52260045 DS10014522 BI MENTUM RK PE LINER 22 45 | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU | MEH | S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION | 2002676A | 03662200015511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |