FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28
MDR report key: 7793277
·
Received August 17, 2018
Report
- Report Number
- 3005180920-2018-00614
- Event Type
- Injury
- Date Received
- August 17, 2018
- Date of Event
- July 19, 2018
- Report Date
- August 17, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030807244
- PMA / PMN Number
- K092265
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 17 AUGUST 2018. LOT 123411: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 OCTOBER 2012. EXPIRATION DATE: 2017-09-30 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION DUE TO SIGNS OF INFECTION 5 YEARS AND 7 MONTHS AFTER PRIMARY. PATHOGEN NOT AVAILABLE. THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633421 | VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28 | DOUBLE MOBILITY LINER | MEH | MEDACTA INTERNATIONAL SA | 123411 | 07630030807244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |