FDA Adverse Event
Injury
Summary report: N
ORTHOLOC ADVANTIM LSI TIBIAL INSERT
MDR report key: 282431
·
Received June 16, 2000
Report
- Report Number
- 1043534-2000-00054
- Event Type
- Injury
- Date Received
- June 16, 2000
- Date of Event
- April 27, 2000
- Report Date
- May 16, 2000
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KRP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ORIG SURG: 1993. MODERATELY ACTIVE PT. PT ALLEGEDLY COMPLAINED OF PAIN. REVISION SURGERY PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOLOC ADVANTIM LSI TIBIAL INSERT | KNEE COMPONENT | KRP | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 112M809590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |