FDA Adverse Event
Injury
Summary report: N
PROVEN GEN-FLEX MODULAR/REVISION KNEE SYSTEM
MDR report key: 3100077
·
Received May 8, 2013
Report
- Report Number
- 2530191-2013-00005
- Event Type
- Injury
- Date Received
- May 8, 2013
- Date of Event
- March 27, 2013
- Report Date
- May 8, 2013
- Manufacturer
- STELKAST INC.
- Product Code
- JWH
- PMA / PMN Number
- K030577
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
PATIENT UNDERWENT REVISION SURGERY OF A RIGHT TOTAL KNEE ARTHROPLASTY. INTRA-OP PER SURGEON NOTED THAT FEMORAL COMPONENT TO BE LOOSE ON THE END OF THE FEMUR AND HAD FRACTURED AT ITS ATTACHMENT SITE. THE VALGUS BUSHING WAS NO LONGER ATTACHED TO THE FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200752 | PROVEN GEN-FLEX MODULAR/REVISION KNEE SYSTEM | PROVEN GEN-FLEX MODULAR/REVISION KNEE SYSTEM | JWH | STELKAST INC. | SC2236-2, SC2193-5 | 18667-010308, 23211-063010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |