FDA Adverse Event
Injury
Summary report: N
HMRS ROT HINGE TIB ROT COMP
MDR report key: 2171346
·
Received July 18, 2011
Report
- Report Number
- 9610726-2011-00259
- Event Type
- Injury
- Date Received
- July 18, 2011
- Date of Event
- June 29, 2011
- Report Date
- June 30, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HSH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HMRS ROT HINGE TIB ROT COMP IMPLANTED ABOUT 10 YEARS AGO WAS BROKEN ON (B)(6) 2011. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HMRS ROT HINGE TIB ROT COMP | IMPLANT | HSH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |