FDA Adverse Event
Injury
Summary report: N
VERSAFITCUT CC FLAT PE LINER
MDR report key: 4643405
·
Received March 27, 2015
Report
- Report Number
- 3005180920-2015-00047
- 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 050070: (B)(4) LINERS PRODUCED AND RELEASED ON 08/17/2005. NO ANOMALIES FOUND. TO DATE, ALL THE ITEMS HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. THE LINER HAS BEEN RECEIVED BACK AND NOT INSPECTED YET. A FOLLOW UP WILL BE SUBMITTED WITH THE OUTCOMES OF THE ANALYSIS. THE CERAMIC BALL HEAD - MANUFACTURED BY (B)(4) AND NOT MARKETED IN THE USA - BROKE DURING THE REVISION SURGERY AND WAS NOT SENT BACK: INFO RECEIVED ON 03/26/2015.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204943 | VERSAFITCUT CC FLAT PE LINER | FLAT UHMWPE LINER, LZO, MEH | LZO | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |