FDA Adverse Event
Injury
Summary report: N
ADVANCE(R) TOT COND FEMORAL NON-POROUS
MDR report key: 7151361
·
Received December 28, 2017
Report
- Report Number
- 3010536692-2017-01619
- Event Type
- Injury
- Date Received
- December 28, 2017
- Date of Event
- July 5, 2017
- Report Date
- December 12, 2017
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- JWH
- PMA / PMN Number
- K974328
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 1
ALLEGEDLY THE PATIENT HAD A PRIMARY TKR USING AMP ON XXX. ALLEGEDLY THE TIBIAL BASE PLATE SUBSIDE BY APPROX 30 DEGREES AND ALLEGEDLY A REVISION WAS PERFORMED. ALLEGED USE OF 2X 14 MM MEDIAL PIVOT INSERT DURING THE REVISION. ADDITIONAL INFORMATION RECEIVED FROM NJR ON 12/12/2017: ALLEGEDLY, PATIENT WAS REVISED DUE TO OTHER INDICATION FOR REVISION (LEFT) REVISION NJR NUMBER: (B)(4). PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 930408 | ADVANCE(R) TOT COND FEMORAL NON-POROUS | KNEE COMPONENT | JWH | MICROPORT ORTHOPEDICS INC. | KFTC-NP2L | 1666211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |