FDA Adverse Event
Injury
Summary report: N
UNKNOWN SCORPIO 5MM PATELLA COMPONENT
MDR report key: 1893423
·
Received November 4, 2010
Report
- Report Number
- 2249697-2010-01467
- Event Type
- Injury
- Date Received
- November 4, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2010-01464; 2249697-2010-01465 & 2249697-2010-01466. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT HAD BILATERAL REVISION OF PATELLAS AND OF TIBIAL INSERTS. NEW PATELLAS AND NEW AND NEW INSERTS WERE IMPLANTED." THE PER IS REPORTING LEFT KNEE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SCORPIO 5MM PATELLA COMPONENT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |