FDA Adverse Event
Injury
Summary report: N
ZIMMER PATIENT SPECIFIC INSTRUMENT
MDR report key: 3556662
·
Received December 23, 2013
Report
- Report Number
- 3003998208-2013-00008
- Event Type
- Injury
- Date Received
- December 23, 2013
- Date of Event
- October 9, 2013
- Report Date
- December 2, 2013
- Manufacturer
- MATERIALISE N.V.
- Product Code
- MBH
- PMA / PMN Number
- K121640
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE INTERNAL DOCUMENTATION DID NOT SHOW AN ANOMALY OR DEVIATION. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENT GUIDES. A VALGUS DEFORMITY WAS FOUND POST-OPERATIVE. PATIENT UNDERWENT A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672457 | ZIMMER PATIENT SPECIFIC INSTRUMENT | MBH, JWH | MBH | MATERIALISE N.V. | 00-5970-000-25 | 56566877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |