FDA Adverse Event
Injury
Summary report: N
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28
MDR report key: 9174381
·
Received October 10, 2019
Report
- Report Number
- 3005180920-2019-00858
- Event Type
- Injury
- Date Received
- October 10, 2019
- Date of Event
- September 11, 2019
- Report Date
- October 10, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- MEH
- UDI-DI
- 07630030807282
- PMA / PMN Number
- K092265
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 23-SEP-2019: LOT 1901455: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 2024-MAY-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AFTER ABOUT 1 MONTH, THE PATHOGEN IS (B)(6). THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA VERSAFITCUP DM LINER HC 50/28 WITH A MEDACTA VERSAFITCUP DM LINER HC 50/28. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 967889 | LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28 | HIP SHELL LINER | MEH | MEDACTA INTERNATIONAL SA | 1901455 | 07630030807282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |