FDA Adverse Event
Malfunction
Summary report: N
VERSAFITCUP CC TERMINAL CUP IMPACTOR
MDR report key: 3888124
·
Received June 4, 2014
Report
- Report Number
- 3005180920-2014-00068
- Event Type
- Malfunction
- Date Received
- June 4, 2014
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEWS: FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1210174-27 INSTRUMENTS PRODUCED) NO ANOMALIES WERE FOUND. NO SIMILAR ISSUES HAVE BEEN REGISTERED WITH ITEMS OF THE SAME LOT. VERSAFITCUP CC TRIO ACETABULAR SHELL (K122911: CODE 01.26.45.1154 LOT 140089: (B)(4)SHELLS MANUFACTURED AND (B)(4)ALREADY SOLD. NO ANOMALIES WERE FOUND FROM THE DOCUMENT REVIEW; NO SIMILAR CASES WITH ITEMS OF THE SAME LOT. THE FAILURE MODE IS UNLIKELY TO CAUSE PT HARM, EVEN IF IT CAN LEAD TO ADDITIONAL STEPS TO FIX THE PROBLEM.
Description of Event or Problem · 1
REF IMP# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327731 | VERSAFITCUP CC TERMINAL CUP IMPACTOR | REUSABLE SURGICAL INSTRUMENT FOR HIP | MEH | MEDACTA INTERNATIONAL SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |