FDA Adverse Event
Injury
Summary report: N
SCORPIO FEMORAL COMPONENT
MDR report key: 2090126
·
Received May 5, 2011
Report
- Report Number
- 2249697-2011-00666
- Event Type
- Injury
- Date Received
- May 5, 2011
- Date of Event
- March 21, 2011
- Report Date
- April 18, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2011-00665.
Description of Event or Problem · 1
A PT UNDERWENT A SURGICAL PROCEDURE OF RIGHT TOTAL KNEE REPLACEMENT DUE TO GONARTHRITIS IN 2008. ON (B)(6) 2011 THE PT UNDERWENT AN UNANTICIPATED REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO FEMORAL COMPONENT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |