FDA Adverse Event
Injury
Summary report: N
ZIMMER PATIENT SPECIFIC INSTRUMENT
MDR report key: 2864382
·
Received December 6, 2012
Report
- Report Number
- 3003998208-2012-00013
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- June 29, 2012
- Report Date
- November 8, 2012
- Manufacturer
- MATERIALISE N.V.
- Product Code
- MBH
- PMA / PMN Number
- K112301
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE INTERNAL DOCUMENTATION IS IN PROGRESS. INSUFFICIENT INFORMATION IS CURRENTLY AVAILABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED WHEN THE INVESTIGATION IS CONCLUDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING ZIMMER PATIENT SPECIFIC INSTRUMENT GUIDES. POST-OPERATIVE X-RAYS SHOWED THE TIBIA CUT IS HAS AN ANTERIOR SLOPE OF 5 DEGREES, AND THE KNEE IS IN VALGUS. THE SURGEON INFORMED US THAT A REVISION SURGERY WILL BE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER PATIENT SPECIFIC INSTRUMENT | MBH, JWH | MBH | MATERIALISE N.V. | 00-5970-000-04 | 12.068460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention| S |