FDA Adverse Event
Injury
Summary report: N
INFINITY HIP
MDR report key: 91897
·
Received May 14, 1997
Report
- Report Number
- 1043534-1997-00059
- Event Type
- Injury
- Date Received
- May 14, 1997
- Date of Event
- July 17, 1996
- Report Date
- May 13, 1997
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT RETURNED FOR INVESTIGATION. PRODUCT WAS MFG AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MED TECHNOLOGY, INC. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-1997-00088, 00089, 00090, AND 00091.
Description of Event or Problem · 1
FAILED R THR - STEM MIGRATED. PT HAD A FEM FRACTURE + SPLIT, AND A LOOSE CUP COMPONENT WEAR AND MIGRATION OF SHELL. REVISION DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITY HIP Implant | HIP COMPONENT | JDI | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 122M833650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |