TRIATHLON CR X3 TIBIAL INSERT
Received Oct 24, 2012 · Event occurred Oct 8, 2012
Report 2249697-2012-02017 · MDR key 2821523
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
5530-G-413
Lot number
9VLMKD
Product problems
- Material Fragmentation
- Unstable
Patient
53 YR
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DR (B)(6) SAID, THE PATIENT CAME IN REPORTING SOME PAIN AND INSTABILITY. HE THOUGHT A THICKER POLY WOULD HELP WITH THE INSTABILITY AND THE DEEPER DISH OF THE CS POLY SO HE REMOVED THE OLD CR 4X13X3 CR POLY AND REPLACED IT WITH A 4X19MM CS X3 POLY. AFTER REMOVING THE POLY, IT WAS DISCOVERED THAT THE POSTERIOR MEDIAL SIDE OF THE POLY HAD A PIECE THAT WAS CHIPPED OFF THE PIECE WAS RETRIEVED AND IS AT THE HOSPITAL.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other