FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM
MDR report key: 13264901
·
Received January 17, 2022
Report
- Report Number
- 3005180920-2022-00024
- Event Type
- Injury
- Date Received
- January 17, 2022
- Date of Event
- December 21, 2021
- Report Date
- January 17, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030895647
- PMA / PMN Number
- K162084
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 22 DECEMBER 2021: LOT 163690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2016. EXPIRATION DATE: 2021-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.
Description of Event or Problem · 0
REVISION SURGERY AT 3 YEARS AND 4 MONTHS AFTER PRIMARY DUE TO FEMORAL COMPONENT LOOSENING. THE SURGEON REVISED THE JOINT IMPLANTING A TOTAL KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610560 | MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM | CEMENTED ANATOMICAL FEMORAL COMPONENT | HSX | MEDACTA INTERNATIONAL SA | 02.18.006RM | 163690 | 07630030895647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention |