FDA Adverse Event
Injury
Summary report: N
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46
MDR report key: 9150280
·
Received October 3, 2019
Report
- Report Number
- 3005180920-2019-00843
- Event Type
- Injury
- Date Received
- October 3, 2019
- Date of Event
- September 11, 2019
- Report Date
- October 3, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030807749
- PMA / PMN Number
- K103352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2019. LOT 122958: 50 ITEMS MANUFACTURED AND RELEASED ON 08-SET-2012. EXPIRATION DATE: 2017-07-31. 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.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED ALMOST 6 YEARS AND 7 MONTHS AFTER PRIMARY FOLLOWING CUP MOBILIZATION. HEAD, CUP AND LINER HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 947983 | CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46 | HIP ACETABULAR SHELL | LZO | MEDACTA INTERNATIONAL SA | 122958 | 07630030807749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |