FDA Adverse Event
Malfunction
Summary report: N
BIMOBILE DUAL MOBILITY SYSTEM
MDR report key: 18570366
·
Received January 24, 2024
Report
- Report Number
- 3004371426-2024-00012
- Event Type
- Malfunction
- Date Received
- January 24, 2024
- Date of Event
- January 1, 2024
- Report Date
- January 11, 2024
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- MEH
- UDI-DI
- 04026575230747
- PMA / PMN Number
- K190535
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
A DATA RESEARCH OF THE LABELS HAD BEEN CONDUCTED. THE PRODUCT RECALL R-2024-01 IS BEING FINALIZED.
Additional Manufacturer Narrative · 0
A DATA RESEARCH OF THE LABELS HAD BEEN CONDUCTED. PRODUCT RECALL R-2024-01 IS INITIATED.
Description of Event or Problem · 0
LABELING "F INSTEAD OF G".
Description of Event or Problem · 0
LABELING "F INSTEAD OF G"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1899222 | BIMOBILE DUAL MOBILITY SYSTEM | LINER, X-LINKED VIT-E PE, I.D.= 28MM, FOR SHELL O.D. 70 MM | MEH | WALDEMAR LINK GMBH & CO. KG | 184-280/12 | 2325426 | 04026575230747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |