FDA Adverse Event
Injury
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 50MM
MDR report key: 3191697
·
Received June 26, 2013
Report
- Report Number
- 0002249697-2013-02081
- Event Type
- Injury
- Date Received
- June 26, 2013
- Date of Event
- April 23, 2013
- Report Date
- April 23, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT AND IS THEREFORE CONSIDERED CONCOMITANT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THE INVESTIGATION WILL BE REOPENED.
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
REVISED CERAMIC ACETABULAR CUP AND HEAD. UPON REMOVAL OF CUP SURGEON FOUND THAT THE CERAMIC HAD BROKEN AWAY FROM THE METAL BACKING.
Description of Event or Problem · 1
REVISED CERAMIC ACETABULAR CUP AND HEAD. UPON REMOVAL OF CUP, SURGEON FOUND THAT THE CERAMIC HAD BROKEN AWAY FROM THE METAL BACKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290382 | TRIDENT HEMISPHERICAL CLUSTER 50MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH | 9856301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| O| R |