FDA Adverse Event
Injury
Summary report: N
MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM
MDR report key: 13800588
·
Received March 17, 2022
Report
- Report Number
- 3005180920-2022-00172
- Event Type
- Injury
- Date Received
- March 17, 2022
- Date of Event
- February 15, 2022
- Report Date
- March 17, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- HSX
- UDI-DI
- 07630030895869
- 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 16 FEBRUARY 2022. LOT 082700: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2008. EXPIRATION DATE: 2013-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30315 | MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM | TIBIAL INSERT FIX | HSX | MEDACTA INTERNATIONAL SA | 02.18.IF2.08.RM | 186676 | 07630030895869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |