FDA Adverse Event
Malfunction
Summary report: N
BIMOBILE DUAL MOBILITY SYSTEM
MDR report key: 22541533
·
Received July 18, 2025
Report
- Report Number
- 3004371426-2025-00034
- Event Type
- Malfunction
- Date Received
- July 18, 2025
- Date of Event
- July 1, 2025
- Report Date
- July 1, 2025
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- MEH
- PMA / PMN Number
- K171273
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.
Additional Manufacturer Narrative · 0
THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATIONS.
Description of Event or Problem · 0
MICROCRACKING OF PE LINER.
Description of Event or Problem · 0
MICROCRACKING OF PE LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1195470 | BIMOBILE DUAL MOBILITY SYSTEM | LINER, UHMWPE, I.D.= 22MM, FOR SHELL O.D. 42 MM | MEH | WALDEMAR LINK GMBH & CO. KG | 184-250/01 | 2203200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |