FDA Adverse Event
Malfunction
Summary report: N
ZIMMER CEMENT MIXING SYSTEM
MDR report key: 1013996
·
Received March 13, 2008
Report
- Report Number
- 1526350-2008-00019
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- December 14, 2007
- Report Date
- January 24, 2008
- Manufacturer
- ZIMMER ORTHOPAEDIC SURG. PROD.
- Product Code
- JDZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CAUSE OF THE BREAKAGE IS UNKNOWN.
Description of Event or Problem · 1
WHILE APPLYING CEMENT TO THE TIBIA. THE SURGEON NOTICED A BROKEN PIECE OF PLASTIC IN THE CEMENT. AFTER REMOVING FROM PATIENT. HE DISASSEMBLED THE CEMENT MIXER TO DISCOVER, IT WAS PART OF THE MIXING PADDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER CEMENT MIXING SYSTEM | CEMENT MIXING SYSTEM | JDZ | ZIMMER ORTHOPAEDIC SURG. PROD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |