FDA Adverse Event
Injury
Summary report: N
VERSAFIT CC FLAT PE HC LINER
MDR report key: 4643419
·
Received March 27, 2015
Report
- Report Number
- 3005180920-2015-00046
- Event Type
- Injury
- Date Received
- March 27, 2015
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LZO
- PMA / PMN Number
- K103352
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 03/25/2015: LOT 142641: (B)(4) LINERS PRODUCED AND RELEASED ON 06/24/2014. NO ANOMALIES FOUND RELATED TO THE ISSUE REPORTED. TO DATE, (B)(4) LINERS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR PROBLEM. ON (B)(4) 2015, (B)(4) MADE THE BATCH REVIEW OF THE CERAMIC HEAD, WITHOUT ANY ANOMALY REPORTED. ON 03/24/2015, WE WERE INFORMED THAT THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR EVAL.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205151 | VERSAFIT CC FLAT PE HC LINER | FLAT UHMWPE HC LINER, LZO, MEH | LZO | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |