GMRS DIST FEM COMP STD R 65MM
Received Jul 22, 2026 · Event occurred Jun 25, 2026
Report 0002249697-2026-00645 · MDR key 25908015
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Stryker Orthopaedics-mahwahCatalog number
64952040
Lot number
YX92B
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
29 YR · Female
- Pain
Narrative
Description of Event or Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF GMRS STEM, EXTENSION PIECE, DISTAL FEMUR, AND BEARING COMPONENTS. PT COMPLAINING OF PAIN. PI SUBMITTED FOR PREVIOUS REVISION.
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# DEVICE NAME LOT# 64812130 MRHK BUMPER INSERT - NEUTRAL LNH351. 64812110 MRHK FEMORAL BUSHING LNS905. 64812120 MRH AXLE CTD125791. 64956050 GMRS EXTENSION PIECE 50MM ED6MH. 64812100 MRH TIB ROT COMP XS-XL 220107. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.