STRYKER CUP
Received Apr 1, 2026 · Event occurred Mar 23, 2026
Report MW5186310 · MDR key 24764668
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Stryker Ireland OsteonicsPatient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A DISLOCATION. THE STRYKER CUP WAS REMOVED AS WELL AS THE 20X15X165 SROM STEM AND 28MM SROM HEAD. DOCTOR WANTED TO REMOVE THE STEM IN ORDER TO PROVIDE MORE ROOM AND VISIBILITY TO THE ACETABULUM. A NEW GRIPTION CUP WAS IMPLANTED, A NEW 20X15X165 STEM, AND A 36MM +6 CERAMIC HEAD. THE HIP WAS REDUCED AND STABILITY WAS CONFIRMED. THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).