FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP ACETABULAR SHELL CC Ø 48
MDR report key: 7938069
·
Received October 5, 2018
Report
- Report Number
- 3005180920-2018-00752
- Event Type
- Injury
- Date Received
- October 5, 2018
- Date of Event
- September 5, 2018
- Report Date
- October 5, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030808036
- PMA / PMN Number
- K083116
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 02 OCTOBER 2018; LOT 172585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 SEPTEMBER 2009. EXPIRATION DATE: 2014-08-31; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED DUE TO CUP LOOSENING 8 YEARS AND 7 MONTHS. THE SURGEON REVISED THE CUP, HEAD AND LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780405 | VERSAFITCUP ACETABULAR SHELL CC Ø 48 | ACETABULAR SHELL | MEH | MEDACTA INTERNATIONAL SA | 091851 | 07630030808036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |