FDA Adverse Event
Injury
Summary report: N
P.F.C. MODULAR KNEE SYSTEM OVAL PATELLA COMPONENT
MDR report key: 71296
·
Received February 26, 1997
Report
- Report Number
- 1219655-1997-00045
- Event Type
- Injury
- Date Received
- February 26, 1997
- Date of Event
- December 9, 1996
- Report Date
- February 26, 1997
- Manufacturer
- JOHNSON & JOHNSON PROFESSIONAL, INC.
- Product Code
- HTG
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H3, H6 - NON-DESTRUCTIVE VISUAL EVALUATION WAS PERFORMED ON THE PATELLA COMPONENT. THE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE PATELLA WAS REVISED BECAUSE OF FRACTURE OF THE BONE CEMENT AND THE THREE FIXATION POSTS. THE ARTICULATING SURFACE OF THE PATELLA SHOWED LIMITED BURNISHING AND DEFORMATION IN THE INFERIOR-LATERAL QUADRANT. THERE WERE NO APPARENT MATERIAL OR MFG DEFECTS NOTED ON THE COMPONENT.
Description of Event or Problem · 1
REVISION KNEE SURGERY PERFORMED DUE TO SHEARING OFF OF THE SUBJECT PATELLA COMPONENT'S U.H.M.W.P.E. PEGS AS WELL AS POLY WEAR AND PITTING ON THE ARTICULATING SURFACE OF A TIBIAL INSERT COMPONENT, CATALOG NO: 86-4157, MFG REPORT NO. 1219555-1997-00046.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | P.F.C. MODULAR KNEE SYSTEM OVAL PATELLA COMPONENT Implant | OVAL PATELLA COMPONENT, U.H.M.W.P.E. | HTG | JOHNSON & JOHNSON PROFESSIONAL, INC. | NA | 693BD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |