FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL MULTI
MDR report key: 1221903
·
Received November 4, 2008
Report
- Report Number
- 9616680-2008-00367
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- July 10, 2007
- Report Date
- October 7, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO (X-RAYS, MEDICAL RECORDS, OPERATIVE REPORT) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY PT'S SON AND HUSBAND THAT PT HAS BEEN EXPERIENCING PAIN WITHIN TWO WEEKS OF THE SURGERY (RIGHT LEG ABOVE THE KNEE). PT HAS SEEN A SPINE SPECIALIST FOR BACK PROBLEMS AND THEY TOLD HER THAT THE PAIN IS ORIGINATING FROM THE HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL MULTI | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 16143101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |