FDA Adverse Event
Injury
Summary report: N
WHITESIDE ORTHOLOC II METAL BACK PATELLA
MDR report key: 168874
·
Received May 22, 1998
Report
- Report Number
- 1043534-1998-00043
- 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
- HTG
- 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: THERE WAS NO DEVICE FAILURE. ALTHOUGH SEVERAL CONTACTS HAVE BEEN MADE, THE MEDWATCDH 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
REVISION SURGERY PERFORMED. NO COMPLAINT STATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WHITESIDE ORTHOLOC II METAL BACK PATELLA Implant | KNEE COMPONENT | HTG | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 20515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |