FDA Adverse Event
Malfunction
Summary report: N
DEPUY CAPTURED HIP SCREW SIDE PLATE
MDR report key: 111072
·
Received August 4, 1997
Report
- Report Number
- 2020311-1997-00020
- Event Type
- Malfunction
- Date Received
- August 4, 1997
- Date of Event
- March 21, 1997
- Report Date
- May 15, 1997
- Manufacturer
- DEPUY ACE MEDICAL CO.
- Product Code
- KTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 3/21/1997, AN ACE CAPTURED HIP SCREW SYS WAS IMPLANTED IN A 300 LB., 85 YR. OLD FEMALE. ON 03/21/1997, THE SIDE PLATE BROKE AND WAS REMOVED ON 03/22/1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY CAPTURED HIP SCREW SIDE PLATE Implant | INTERNA; HIP FIXATION | KTT | DEPUY ACE MEDICAL CO. | NA | QW2847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |