FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 56MM
MDR report key: 1030067
·
Received April 15, 2008
Report
- Report Number
- 9616680-2008-00089
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 20, 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
- AL, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT HAD BEEN EXPERIENCING PAIN FOR SEVERAL MONTHS. PT WAS BROUGHT TO THE OR IN 2008, AND CULTURES WERE TAKEN THAT REVEALED RARE GRAM POSITIVE COCCI. THE IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 56MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 9925801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |