FDA Adverse Event
Injury
Summary report: N
CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
MDR report key: 15885777
·
Received November 30, 2022
Report
- Report Number
- 3005180920-2022-00898
- Event Type
- Injury
- Date Received
- November 30, 2022
- Date of Event
- November 7, 2022
- Report Date
- November 30, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030810732
- PMA / PMN Number
- K132879
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 10 NOVEMBER 2022. LOT 2102377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2021. EXPIRATION DATE: 2026-05-02. 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
AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2464537 | CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES | HIP CUP | LPH | MEDACTA INTERNATIONAL SA | 01.32.148DH | 2102377 | 07630030810732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |