FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28
MDR report key: 5822366
·
Received July 26, 2016
Report
- Report Number
- 3005180920-2016-00382
- Event Type
- Injury
- Date Received
- July 26, 2016
- Date of Event
- June 30, 2016
- Report Date
- July 26, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- PMA / PMN Number
- K092265
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED ON 08 JULY 2016 AND INCLUDES: THE CUP FROM THE PRIMARY IS A VERSAFIT DM CUP 58MM (CODE 01.26.58MB, LOT 151051 - K083116); NOT EXPLANTED. BATCH REVIEWS PERFORMED ON 20 JULY 2016. (B)(4).
Description of Event or Problem · 1
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATIENT TESTED POSITIVE FOR STAPH. THE SURGEON REVISED THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANTS AND X-RAYS ARE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475064 | VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 58/28 | DOUBLE MOBILITY LINER | MEH | MEDACTA INTERNATIONAL SA | 147781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |