FDA Adverse Event
Injury
Summary report: N
KENE LG M/B PATELLAR DOME
MDR report key: 69308
·
Received February 14, 1997
Report
- Report Number
- 2219689-1997-00082
- Event Type
- Injury
- Date Received
- February 14, 1997
- Date of Event
- January 13, 1997
- Report Date
- February 13, 1997
- Manufacturer
- HOWMEDICA, INC.
- Product Code
- HTG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: THIS DEVICE CAN NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED TO CO BUT RATHER HAS BEEN DISCARDED AT THE HOSPITAL. THE INFORMATION PROVIDED SUGGESTS THAT THIS EVENT IS NOT DEVICE RELATED BUT RATHER IS ASSOCIATED WITH PATIENT INFECTION.
Description of Event or Problem · 1
THE PATELLAR COMPONENT WAS REMOVED DUE TO INFECTION IN THE JOINT. THE FEMORAL AND TIBIAL COMPONENTS WERE ALSO REMOVED AT THIS TIME AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KENE LG M/B PATELLAR DOME Implant | IMPLANT | HTG | HOWMEDICA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention | XXXX-X-XXX KINEMATIC TIVBIAL COMPONENT.| 6471-5-736 KINAMATIC FEMORAL COMPONENT. |