FDA Adverse Event
Injury
Summary report: N
SERIES 7000 STANDARD TIBIA
MDR report key: 1060373
·
Received June 11, 2008
Report
- Report Number
- 2249697-2008-00166
- Event Type
- Injury
- Date Received
- June 11, 2008
- Date of Event
- May 16, 2008
- Report Date
- May 16, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K910990
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "#7 TIBIAL TRAY HAD SUBSIDED MEDIALLY AND LOOSENED. SURGEON REMOVED TRAY AND INSERT AND REPLACED WITH A SCORPIO #9 UNIVERSAL TIBIAL TRAY WITH A FULL 10MM AUGMENT, A 14X155 TIBIAL STEM AND A #9 X 18MM P/S HIGH FLEX INSERT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES 7000 STANDARD TIBIA | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | T04E219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |