FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP CC TRIO, ACETABULAR SHELL DIAM. 46
MDR report key: 5935457
·
Received September 8, 2016
Report
- Report Number
- 3005180920-2016-00467
- Event Type
- Injury
- Date Received
- September 8, 2016
- Date of Event
- August 11, 2016
- Report Date
- September 8, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K103352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 06 SEPTEMBER 2016. LOT 111518: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 JUNE 2011. EXPIRATION DATE: 2016-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION DUE TO PAIN: THE WHOLE HIP PROSTHESIS HAS BEEN TAKEN OUT. THE REASON OF HER PAIN WAS THAT THE CUP WAS IN A BAD POSITION (TOO MUCH LATERALIZED). EXPLANTS WILL NOT BE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 588801 | VERSAFITCUP CC TRIO, ACETABULAR SHELL DIAM. 46 | ACETABULAR SHELL | LZO | MEDACTA INTERNATIONAL SA | 111518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |