FDA Adverse Event
Malfunction
Summary report: N
ALLEN MEDULLARY CEMENT PLUGS
MDR report key: 1694858
·
Received May 14, 2010
Report
- Report Number
- 1822565-2010-00329
- Event Type
- Malfunction
- Date Received
- May 14, 2010
- Date of Event
- February 7, 2007
- Report Date
- February 7, 2007
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE MANUFACTURED LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THIS KIND AND APPEARS TO BE AN ISOLATED INSTANCE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. (B)(4). TOTAL NUMBER OF EVENTS: 1. REASON FOR EXEMPTION: THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON FOUND A HAIR-LIKE SUBSTANCE THAT WAS TRAPPED BETWEEN THE TYVEK AND THE FILM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEN MEDULLARY CEMENT PLUGS | IMPLANT | JDK | ZIMMER, INC. | NA | 60471449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |