FDA Adverse Event
Malfunction
Summary report: N
ZUK ARTICULAR SURFACE PROVISIONAL
MDR report key: 2093922
·
Received April 19, 2011
Report
- Report Number
- 1822565-2011-00968
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 22, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BOTH TRIALS ARE BROKEN IN HALF AT THE MEDIAL PORTION OF THE NOTCHES. WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. DIMENSIONAL ANALYSIS FOUND THE PARTS TO BE CONFORMING WHERE MEASURED. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO TRIAL INSTRUMENTS BROKE IN HALF DURING KNEE TRIAL REDUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZUK ARTICULAR SURFACE PROVISIONAL | LXH | ZIMMER INC | 60250799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | 00584102408, LOT #61089332| ZUK ARTICULAR SURFACE PROVISIONAL: CATALOG # |