FDA Adverse Event
Injury
Summary report: N
DALL MILES CABLE
MDR report key: 211297
·
Received February 23, 1999
Report
- Report Number
- 2219689-1999-00036
- Event Type
- Injury
- Date Received
- February 23, 1999
- Date of Event
- April 21, 1992
- Report Date
- February 22, 1999
- Manufacturer
- HOWMEDICA INC.
- Product Code
- JDQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
REPORTER STATED, "IN AUGUST OR SEPTEMBER 1990, THE PLAINTIFF UNDERWENT SURGERY FOR A REPLACEMENT OF HER RIGHT HIP. ON APRIL 21, 1992, IT WAS REPORTED THAT THE SYSTEM HAD FAILED AND THE PLAINTIFF UNDERWENT A SECOND SURGERY TO REMOVE A PORTION OF THE IMPLANTED SYSTEM THAT ALLEGEDLY HAD FAILED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DALL MILES CABLE Implant | IMPLANT | JDQ | HOWMEDICA INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |