DOUBLE MOBILITY LINER
Report
- Report Number
- 3005180920-2025-00084
- Event Type
- Injury
- Date Received
- February 21, 2025
- Date of Event
- January 27, 2025
- Report Date
- February 21, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030807411
- PMA / PMN Number
- K092265
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
BATCH REVIEW PERFORMED ON 30 JANUARY 2025: LOT 2414823: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2024. EXPIRATION DATE: 2029-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: CUP: MPACT 01.32.156MB DOUBLE MOBILITY ACETABULAR SHELL Ø56 (K143453) LOT 2405841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2024. EXPIRATION DATE: 2029-07-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.
DURING POST-OP RECOVERY AFTER THE PRIMARY HIP SURGERY (THE SAME DAY OF PRIMARY SURGERY), THE PATIENT HIP LUXATED, THE LINER FROM THE CUP. THE SURGEON REVISED THE PATIENT'S HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1667695 | DOUBLE MOBILITY LINER | LINER: MPACT DM 01.26.2856MHC DOUBLE MOBILITY HC LINER 28/DMH | MEH | MEDACTA INTERNATIONAL SA | 01.26.2856MHC | 2414823 | 07630030807411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention |