FDA Adverse Event
Injury
Summary report: N
SCORPIO-FLEX PS X3 TIB INSERT
MDR report key: 1101774
·
Received July 25, 2008
Report
- Report Number
- 2249697-2008-00221
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 30, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K051977
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT; "AFTER KNEE ARTHROPLASTY SURGERY ON BOTH KNEE IN 2008, THE PT GOT THE REVISION SURGERY ON HER RIGHT KNEE TWO MONTHS LATER. THIS PT VISITED HOSP AGAIN FELT PAIN ON HER LEFT KNEE. DURING ARTHROSCOPE, SURGEON FOUND OUT THE INSERT POST WAS BROKEN, AND INSERT REVISION SURGERY WAS DONE IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO-FLEX PS X3 TIB INSERT | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | TYNMJD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |