FDA Adverse Event
Injury
Summary report: N
ADVANCE(R) II TIBIAL BASE
MDR report key: 6110283
·
Received November 17, 2016
Report
- Report Number
- 3010536692-2016-01413
- Event Type
- Injury
- Date Received
- November 17, 2016
- Report Date
- October 24, 2016
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- HRY
- PMA / PMN Number
- K960617
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Additional Manufacturer Narrative · 1
UPON REASSESSMENT OF THE REPORTED EVENT WE HAVE DETERMINED THAT THIS IS A DUPLICATE THAT WAS PREVIOUSLY REPORTED UNDER (B)(4).
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA; MAL-ALIGNMENT; STIFFNESS; WEAR OF POLYETHYLENE COMPONENT.(RIGHT) AGE AT PRIMARY: (B)(6). PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING. REVISION NJR INDEX NO: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760910 | ADVANCE(R) II TIBIAL BASE | KNEE COMPONENT | HRY | MICROPORT ORTHOPEDICS INC. | 55229097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |