FDA Adverse Event
Injury
Summary report: N
UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
MDR report key: 1274997
·
Received December 23, 2008
Report
- Report Number
- 3004154314-2008-00001
- Event Type
- Injury
- Date Received
- December 23, 2008
- Date of Event
- November 17, 2008
- Report Date
- December 17, 2008
- Manufacturer
- ARTHROSURFACE, INC.
- Product Code
- HSX
- PMA / PMN Number
- K050373
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AT MOST RECENT FOLLOW-UP, PATIENT IS PAIN FREE AND PROGRESSING WELL.
Description of Event or Problem · 1
PERI-PROSTHETIC FRACTURE FOLLOWING UNICONDYLAR KNEE REPLACEMENT. PATIENT PRESENTED WITH PAIN APPROXIMATELY THREE WEEKS POST IMPLANTATION. FRACTURE WAS CONFIRMED RADIOGRAPHICALLY. PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION. IMPLANTS WERE FOUND TO BE RIGIDLY FIXED AND LEFT IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS | UNICAP | HSX | ARTHROSURFACE, INC. | K205-0510 | 75AH0807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |