FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP CC TRIO ACETABULAR SHELL
MDR report key: 4346586
·
Received December 9, 2014
Report
- Report Number
- 3005180920-2014-00174
- Event Type
- Injury
- Date Received
- December 9, 2014
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LZO
- PMA / PMN Number
- K103352
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: VERSAFITCUP CC TRIO SHELL CEMENTLESS SIZE 54: REF. 01.26.45.0054/LOT 113308 ((B)(4) CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
IMP REFERENCE - (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792808 | VERSAFITCUP CC TRIO ACETABULAR SHELL | ACETABULAR CEMENTLESS CUP 54 | LZO | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |