FDA Adverse Event
Malfunction
Summary report: N
COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
MDR report key: 1163393
·
Received September 10, 2008
Report
- Report Number
- 1822565-2008-00591
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- July 30, 2008
- Report Date
- August 11, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: DUE TO NORMAL VARIATION IN PRODUCT WITHIN ITS SPECIFIED TOLERANCE BANDS, THE FIT CONDITION CAN VARY AMONG THE BUSHINGS, PINS, AND HUMERAL COMPONENT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING SURGERY IN 2008, THE HINGE WOULD NOT ALIGN PROPERLY BETWEEN THE ULNA AND HUMERAL COMPONENT CAUSING A 1.5 HOUR DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY | ELBOW PROSTHESIS | JDC | ZIMMER, INC. | NA | 60137926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |