FDA Adverse Event
Malfunction
Summary report: N
VERSAFITCUP SHELL
MDR report key: 2363459
·
Received December 2, 2011
Report
- Report Number
- 3005180920-2011-00061
- Event Type
- Malfunction
- Date Received
- December 2, 2011
- Date of Event
- November 9, 2011
- Report Date
- December 2, 2011
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- MEH
- PMA / PMN Number
- K083116
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW. VERSAFITCUP ACETABULAR SHELL - (B)(4) LOT 112856: (B)(4). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MFG. TEN CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE FAILURE OF THE PRESS FIT OCCURRED (B)(4) TIMES IN THE PAST, IN THE 2010 (MDR 2010-00024; 210-00027; 2010-00029) AND, UP TO NOW, (B)(4). AS IN THE PAST, ALSO THIS CASE IS HIGH LIKELY ASSOCIATED WITH A WRONG REAMING TECHNIQUE AND THE EVENT IS THOUGHT TO BE NOT DEVICE RELATED.
Description of Event or Problem · 1
THE VERSAFITCUP CUP CAME LOOSE WHEN THE HIP WAS REDUCED. AFTER 3 ATTEMPTS MADE, THE DOCTOR SWITCHED TO ANOTHER CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSAFITCUP SHELL | ACTABULAR SHELL CEMENTLESS | MEH | MEDACTA INTERNATIONAL, SA | 112856 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |