FDA Adverse Event
Injury
Summary report: N
CUP: VERSAFITCUP ACETABULAR SHELL Ø 56
MDR report key: 8514352
·
Received April 15, 2019
Report
- Report Number
- 3005180920-2019-00276
- Event Type
- Injury
- Date Received
- April 15, 2019
- Date of Event
- March 18, 2019
- Report Date
- April 15, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030808173
- PMA / PMN Number
- K083116
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 APRIL 2019: LOT 114528: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2012. EXPIRATION DATE: 2017-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2 (K093944), LOT 120133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAR-2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ABOUT 6 YEARS AFTER PRIMARY REVISION SURGERY FOR CUP/STEM IMPINGEMENT. THE SURGEON REVISED THE PATIENT CUP, STEM, LINER AND CERAMIC HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307699 | CUP: VERSAFITCUP ACETABULAR SHELL Ø 56 | CEMENTLESS ACETABULAR SHELL | MEH | MEDACTA INTERNATIONAL SA | 114528 | 07630030808173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |