FDA Adverse Event
Injury
Summary report: N
WHITESIDE ORTHOLOC II FEMORAL PROSTHESIS
MDR report key: 168873
·
Received May 22, 1998
Report
- Report Number
- 1043534-1998-00044
- Event Type
- Injury
- Date Received
- May 22, 1998
- Date of Event
- April 9, 1998
- Report Date
- April 23, 1998
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. ALTHOUGH SEVERAL CONTACTS HAVE BEEN MADE, THE MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.
Description of Event or Problem · 1
ALLEGEDLY COMPONENT WAS BROKEN. REVISION SURGERY PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WHITESIDE ORTHOLOC II FEMORAL PROSTHESIS Implant | KNEE COMPONENT | JWH | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 19350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |