FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP ACETABULAR SHELL 50
MDR report key: 10294918
·
Received July 20, 2020
Report
- Report Number
- 3005180920-2020-00447
- Event Type
- Injury
- Date Received
- July 20, 2020
- Date of Event
- June 29, 2020
- Report Date
- July 20, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030808067
- PMA / PMN Number
- K083116
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 133925: 40 ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING GROIN PAIN DUE TO CUP IMPINGEMENT. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD 6 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758620 | VERSAFITCUP ACETABULAR SHELL 50 | HIP UNCEMENTED SHELL | MEH | MEDACTA INTERNATIONAL SA | 01.26.50MB | 133925 | 07630030808067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |