FDA Adverse Event
Injury
Summary report: N
TRIDENT 10 X3 INSERT 32MM ID
MDR report key: 1233920
·
Received November 14, 2008
Report
- Report Number
- 2249697-2008-00364
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 23, 2008
- Report Date
- October 23, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HSH
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL POLICY, THEY KEEP PRODUCTS. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO HAS BEEN REQUESTED. SHOULD DEVICE BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "HIP REVISION. PATIENT WAS UNSTABLE AND REPLACED LINER, CEMENTED LINER. SURGEON ELECTED NOT TO REMOVE SHELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 10 X3 INSERT 32MM ID | IMPLANT | HSH | STRYKER ORTHOPAEDICS MAHWAH | NA | WNDMHE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |