FDA Adverse Event
Injury
Summary report: N
VANTAGE
MDR report key: 11330180
·
Received February 15, 2021
Report
- Report Number
- 1038671-2021-00046
- Event Type
- Injury
- Date Received
- February 15, 2021
- Date of Event
- April 1, 2019
- Report Date
- February 15, 2021
- Manufacturer
- EXACTECH, INC.
- Product Code
- HSN
- UDI-DI
- 10885862276209
- PMA / PMN Number
- K152217
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) TIBIAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICE(S): 350-02-04, 4755507 - TALAR IMPLANT SZ 4 RT, 350-10-04, 5132321 - ANKLE SZ 4 LOCKING CLIP, 350-22-64, 4588357 - TIBIAL INSERT FB SZ 4 RT 12MM.
Description of Event or Problem · 1
APPROXIMATELY 1.5 YEARS POSTOP THE INITIAL ANKLE IMPLANT, THIS MALE PATIENT EXPERIENCED TIBIAL LOOSENING AND WAS REVISED. PATIENT IS DOING WELL NOW. REMOVAL OF VANTAGE IMPLANT. NO OTHER INFORMATION AVAILABLE AS REVISION WAS COMPLETED OUT OF THE CLINICAL STUDY AND NO STUDY ID WAS AVAILABLE. DEVICE IS NOT RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223088 | VANTAGE | TIBIAL PLATE FB SZ 4 RT | HSN | EXACTECH, INC. | 350-12-04 | UNK | 10885862276209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |