FDA Adverse Event
Injury
Summary report: N
TRIDENT 10° X3 INSERT 32MM ID
MDR report key: 3092534
·
Received May 3, 2013
Report
- Report Number
- 0002249697-2013-01535
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 10, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K033716
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT IS A DUPLICATE OF (B)(4). THIS EVENT HAS BEEN REPORTED UNDER MFR REPORT FOR REPORT #0002249697-2013-00997.
Additional Manufacturer Narrative · 1
THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: (B)(4). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193730 | TRIDENT 10° X3 INSERT 32MM ID | IMPLANT | LPH | STRYKER ORTHOPAEDICS-MAHWAH | 73KMND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |