FDA Adverse Event
Malfunction
Summary report: N
VERSAFITCUP CC CUP IMPACTOR
MDR report key: 4347569
·
Received November 21, 2014
Report
- Report Number
- 3005180920-2014-00161
- Event Type
- Malfunction
- Date Received
- November 21, 2014
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LXH
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1112533 - (B)(4) IMPACTORS PRODUCED) NO ANOMALIES WERE FOUND. VERSAFITCUP CC TRIO SHELL (K103352): CODE 01.26.45.0048 LOT 143427: (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
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755987 | VERSAFITCUP CC CUP IMPACTOR | REUSABLE SURGICAL INSTRUMENT FOR HIP | LXH | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |