FDA Adverse Event
Injury
Summary report: N
TRIDENT 10DEG X3 INSERT 32MM ID
MDR report key: 2885179
·
Received December 17, 2012
Report
- Report Number
- 2249697-2012-02707
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- November 18, 2012
- Report Date
- November 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR DUE TO HOSP POLICY. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT BENT OVER AND ROTATED TO PUT ON SOCK AND HIP DISLOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 10DEG X3 INSERT 32MM ID | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | MJNJA5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |