FDA Adverse Event
Injury
Summary report: N
DURA STAB INS W/SCREW LRG 22MM
MDR report key: 1060480
·
Received June 11, 2008
Report
- Report Number
- 2249697-2008-00165
- Event Type
- Injury
- Date Received
- June 11, 2008
- Date of Event
- May 12, 2008
- Report Date
- May 12, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K932070
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DR REMOVED INSERT AND REPLACED WITH 6642-5-325 TOTAL STABILIZER INSERT. THE FEMORAL AND TIBIAL COMPONENTS WERE WELL ALIGNED AND WELL FIXED. DR'S CONCERN WAS THE SIGNIFICANT WEAR ON THE SURFACE OF THE INSERT AND THE TOP OF THE STABILIZER POST ON THE INSERT WAS BROKEN OFF COMPLETELY. THE TWO PIECES WERE REMOVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURA STAB INS W/SCREW LRG 22MM | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | CGSBBC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |