FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
MDR report key: 3181330
·
Received June 21, 2013
Report
- Report Number
- 0002249697-2013-02008
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
AN EVENT REGARDING SUBSIDENCE INVOLVING AN ACCOLADE STEM WAS REPORTED. THIS EVENT RELATES TO ACCOLADE STEM SUBSIDENCE WHICH IS DETAILED IN PR 97454. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SUBSIDENCE. EVIDENCE OF METAL DEBRIS WAS NOTED BY THE SURGEON.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SUBSIDENCE. EVIDENCE OF METAL DEBRIS WAS NOTED BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282029 | TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | 36677401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| O| R |