FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP CC TRIO CUP 52
MDR report key: 4477557
·
Received January 23, 2015
Report
- Report Number
- 3005180920-2015-00006
- Event Type
- Injury
- Date Received
- January 23, 2015
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- MEH
- PMA / PMN Number
- K103352
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: VERSAFITCUP CC TRIO CEMENTLESS SHELL 52: REF 01.26.45.0052 - LOT 122064 ((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. TO DATE ALL THE CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR ISSUE. ON THE BASIS OF THE DATA COLLECTED, WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
IMP REF #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57180 | VERSAFITCUP CC TRIO CUP 52 | CEMENTLESS ACETABULAR SHELL, LZO | MEH | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |