FDA Adverse Event
Injury
Summary report: N
VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 58
MDR report key: 7018031
·
Received November 10, 2017
Report
- Report Number
- 3005180920-2017-00655
- Event Type
- Injury
- Date Received
- November 10, 2017
- Date of Event
- October 13, 2017
- Report Date
- November 10, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030807800
- PMA / PMN Number
- K103352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 10 NOVEMBER 2017. LOT 171698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 AUGUST 2017. EXPIRATION DATE: 2022-08-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE DAY AFTER PRIMARY SURGERY THE HIP LUXATED: SUSPECTED ISSUE WITH THE BALL HEAD LENGTH. TWO DAYS AFTER, A REVISION WAS NEEDED AND THE REASON FOR HIP LUXATION WAS FOUND TO BE A MOBILIZED CUP. THE SURGEON REPLACED THE CUP AND THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796783 | VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 58 | CEMENTLESS ACETABULAR SHELL | LZO | MEDACTA INTERNATIONAL SA | 171698 | 07630030807800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |