FDA Adverse Event
Injury
Summary report: N
CUP: MPACT 3D METAL ACETABULAR SHELL Ø58 TWO-HOLE
MDR report key: 15247649
·
Received August 18, 2022
Report
- Report Number
- 3005180920-2022-00617
- Event Type
- Injury
- Date Received
- August 18, 2022
- Date of Event
- July 19, 2022
- Report Date
- August 18, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030812620
- PMA / PMN Number
- K171966
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 17-AUGUST-2022. LOT 2201526: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2022. EXPIRATION DATE: 2027-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 1 MONTH AFTER THE PRIMARY SURGERY AND IT WAS OBSERVED THAT THE ACETABULAR CUP MOVED AND IS IN PROTRUSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2737320 | CUP: MPACT 3D METAL ACETABULAR SHELL Ø58 TWO-HOLE | HIP ACETABULAR CUP CEMENTLESS | LPH | MEDACTA INTERNATIONAL SA | 01.38.058DH | 2201526 | 07630030812620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |