AMISTEM H CEMENTLESS STEM #4 LAT
Report
- Report Number
- 3005180920-2015-00016
- Event Type
- Injury
- Date Received
- February 9, 2015
- Report Date
- July 29, 2015
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- MEH
- PMA / PMN Number
- K093944
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ON 03/13/2015 WE RECEIVED THE CONFIRMATION THAT THE PIECES WILL NOT BE RETURNED BACK.
ON 07/06/2015 IT WAS PREPARED A FINAL REPOR WITH THE INFORMATION COLLECTED DURING THE INVESTIGATIN, ALREADY REPORTED IN THE INITIAL REPORT AND IN THE FIRST FOLLOW UP. ON 07/07/2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.
BATCH RECORD PERFORMED ON 02/06/2015: LOT 123816: (B)(4) ITEMS PRODUCED AND RELEASED ON 11/21/2012. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. FEMORAL HEAD CODE 01.25.023 LOT 133525 (K072857): (B)(4) ITEMS PRODUCED AND RELEASED ON 09/09/2013. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. VERSAFITCUP CC LINER CODE 01.26.3244HCT LOT 133936 (K103352): (B)(4) ITEMS PRODUCED AND RELEASED ON 10/23/2013. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. VERSAFITCUP CC TRIO NO HOLE SHELL CODE 01.26.45.1154 LOT 133028 (K122911): (B)(4) ITEMS PRODUCED AND RELEASED ON 09/10/2013. NO ANOMALIES FOUND IN THE REVIEW. TO DATE, (B)(4) DEVICES HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE.
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89859 | AMISTEM H CEMENTLESS STEM #4 LAT | CEMENTLESS FEMORAL STEM | MEH | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |