FDA Adverse Event
Injury
Summary report: N
DURACON CRUCIFORM TIBIAL BASEPLATE BEADED
MDR report key: 105939
·
Received July 14, 1997
Report
- Report Number
- 2219689-1997-00371
- Event Type
- Injury
- Date Received
- July 14, 1997
- Date of Event
- April 25, 1997
- Report Date
- July 11, 1997
- Manufacturer
- HOWMEDICA INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: INFO PROVIDED AND THE EXAMINATION RESULTS SUGGEST THAT THIS EVENT IS NOT DEVICE RELATED, BUT RATHER IS ASSOCIATED WITH INSUFFICIENT CORTICAL SUPPORT AND POSSIBLY ALIGNMENT. THIS IS NOT THE SAME PT EVENT AS MFG.#221989-1997-372 AS PREVIOUSLY REPORTED.
Description of Event or Problem · 1
REPORTER STATES, REVISION KNEE SURGERY REVEALED A BROKEN BASEPLATE. BASEPLATE EXPLANTED, AND A UNIVERSAL BASEPLATE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACON CRUCIFORM TIBIAL BASEPLATE BEADED Implant | IMPLANT | JWH | HOWMEDICA INC. | NA | AFCYC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | DURACON STANDARD TIBIAL INSERT, MEDIUM 11MM| CATALOG #6630-1-311, LOT CODE/TTLOA |