Citation 6265-5213Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154316069), received between Apr 3, 2019 and Jun 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Degraded; Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: PT. REPORTED; SHE HAD HER INITIAL HIP REPLACEMENT ON (B)(6) 2010. SHE EXPERIENCED A LOT OF PAIN AND IT STARTED TO DISLOCATE AFTER 11 YEARS. ON (B)(6) 2021, SHE HAD HER 1ST REVISION FOR DISLOCATION. A SECOND HIP REPLACEMENT WHICH WAS ALSO A STRYKER PRODUCT WAS IMPLANTED. SHE HAD COMPLAINTS ABOUT IT FROM THE MOMENT IT WAS PUT IN. IT JUST WASN'T COMFORTABLE IT DIDN'T FEEL RIGHT. THERE WAS A LOT OF PAIN FOR THREE YEARS AND SHE WAS TOLD EVERYTHING WAS FINE THERE WAS NOTHING WRONG WITH THE PRODUCT. ON (B)(6) 2025, SHE WENT FOR A SECOND OPINION AND IT WAS DISCOVERED THAT THE BALL WAS WEARING ON THE STEM CAUSING A RIDGE TO DEVELOP, THE SCREW WHICH HELD THE BALL WAS BROKEN, SHE HAD SEVERE BONE LOSS, AND METAL SHAVINGS BASICALLY FALLEN OFF INTO HER BODY. THE SECOND REVISION WHICH WAS AN EMERGENCY HIP REPLACEMENT WAS PERFORMED (ON (B)(6) 2025) WITH NON-STRYKER IMPLANTS. IT WAS DISCOVERED SHE HAD SEVERE BONE LOSS. PER THE ORTHOPEDIC SURGEON; IT LOOKED LIKE A BOMB HAD GONE OFF ON HER LEG AND THE SURGERY WAS INTENSE. THIS HAS LEFT HER RELYING ON SOME SORT OF WALKING ASSISTANCE DEVICE. PT. FURTHER STATED HER QUALITY OF LIFE HAS COMPLETELY CHANGED; SHE'S BEE

  Patient problems: Insufficient Information; Osteolysis; Pain

  MAUDE report 25659003 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  PATIENT CALLED STRYKER STATING THAT SHE EXPERIENCED 2 DISLOCATIONS ON HER HIP. UPDATE 07-MARCH-2019: IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2010 AND WAS REVISED ON (B)(6) 2015. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8479387 ↗