FDA Adverse Event
Injury
Summary report: N
PCA 7MM, LEFT, STEMMED TIBIAL COM
MDR report key: 625388
·
Received July 12, 2005
Report
- Report Number
- 2249697-2005-00086
- Event Type
- Injury
- Date Received
- July 12, 2005
- Date of Event
- June 8, 2005
- Report Date
- July 12, 2005
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SINCE AROUND 2002 THE PATIENT COMPLAINED OF A PAIN AT THE KNEE, AND THE SURGEON FOUND OSTEOLYSIS BY X-RAYS. FROM 2003 TO 2004 OSTEOLYSIS BY X-RAYS. FROM 2003 TO 2004 OSTEOLYSIS WAS WORSE, AND THE SURGEON FOUND THAT THE TIBAL TRAY BROKE. THE SURGEON PERFORMED REVISION SURGERY IN 2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PCA 7MM, LEFT, STEMMED TIBIAL COM | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | OZFJO2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |