FDA Adverse Event
Injury
Summary report: N
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
MDR report key: 16769103
·
Received April 19, 2023
Report
- Report Number
- 3005180920-2023-00262
- Event Type
- Injury
- Date Received
- April 19, 2023
- Date of Event
- March 22, 2023
- Report Date
- April 19, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030807763
- PMA / PMN Number
- K103352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 24 MARCH 2023. LOT 2000131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2020. EXPIRATION DATE: 2025-05-14. 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 YEARS 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS 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 |
|---|---|---|---|---|---|---|---|
| 1937238 | CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50 | HIP CEMENTLESS CUP | LZO | MEDACTA INTERNATIONAL SA | 01.26.45.0050 | 2000131 | 07630030807763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |