FDA Adverse Event
Injury
Summary report: N
TRIDENT 0° X3 INSERT 36MM ID
MDR report key: 6872477
·
Received September 18, 2017
Report
- Report Number
- 0002249697-2017-02804
- Event Type
- Injury
- Date Received
- September 18, 2017
- Date of Event
- August 1, 2015
- Report Date
- September 18, 2017
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K033716
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 36MM/+7.5MM; CAT# 06-3675; LOT# R10P7R IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.
Description of Event or Problem · 1
PATIENT IS IN CONSTANT PAIN SINCE PRIMARY SURGERY TO HIS LEFT HIP ON OR ABOUT (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654728 | TRIDENT 0° X3 INSERT 36MM ID | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | STRYKER ORTHOPAEDICS-MAHWAH | 9N0N4L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |