QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM
Report
- Report Number
- 3005180920-2015-00153
- Event Type
- Injury
- Date Received
- July 29, 2015
- Report Date
- October 30, 2015
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- JDI
- PMA / PMN Number
- K072857
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ON 01 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 02 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.
BATCH REVIEW PERFORMED ON (B)(6), 2015. QUADRA-S STEM, (B)(4), LOT 100302: (B)(4) ITEMS PRODUCED AND RELEASED ON (B)(6), 2010. NO ANOMALIES FOUND. TO DATE, ALL ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. CANCELLOUS BONE SCREW, FLAT HEAD 6, 5 L 25 (B)(4), LOT 102339 (K103352); (B)(4) ITEMS PRODUCED AND RELEASED ON (B)(6), 2010. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. CANCELLOUS BONE SCREW, FLAT HEAD 6, 5 L 30 (B)(4), LOT 081635 (K103352): (B)(4) ITEMS PRODUCED AND RELEASED ON (B)(6), 2008. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. CERAMIC LINER AND HEAD WERE ALSO EXPLANTED, IMPLANT NOT MARKETED IN US. ON (B)(6), 2015, THE MFR OF THE CERAMIC IMPLANT WAS INFORMED ABOUT THE EVENT. ON JULY 24, 2015, THEY REPLIED THAT NO ANOMALY WAS FOUND IN THEIR PRODUCTION DOCUMENT. MOREOVER, ALSO THE CUP WAS EXPLANTED, IMPLANT NOT MARKET IN US. . NO ANOMALIES FOUND. ON JUNE 30, 2015, WE HAVE BEEN INFORMED THAT X-RAYS AND PIECES WON'T BE AVAILABLE FOR FURTHER INVESTIGATIONS.
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492530 | QUADRA-S CEMENTLESS, SAND BLASTED LAT STEM | CEMENTLESS FEMORAL STEM | JDI | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |