FDA Adverse Event
Injury
Summary report: N
TRIDENT 0? X3 INSERT 36MM ID1
MDR report key: 1060904
·
Received June 13, 2008
Report
- Report Number
- 9616680-2008-00154
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 22, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE WITH ADDITIONAL INFO A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PATIENT CAME IN COMPLAINING OF HIP PAIN, REVISING SURGEON OPENED HER UP, DETERMINED DEVICES WERE NOT LOOSE, PATIENT NOT INFECTED, SO CHANGED THE BEARING SURFACE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0? X3 INSERT 36MM ID1 | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |