Restoration 6276-7-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540643780), received between Sep 8, 2017 and Oct 23, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 18, 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.

• InjuryOct 23, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION1. I HAD THA REVISION SURGERY ON (B)(6) 2018. THE STEM WAS REPLACED WITH A STRYKER RESTORATION MODULAR ONE. THE 28 MM CERAMIC FEMORAL HEAD WAS REPLACED WITH A COCR HEAD. HIP, GROIN, AND THIGH PAIN CONTINUED. ON (B)(6) 2019, I WAS DIAGNOSED WITH A STRESS FRACTURE AT THE TIP OF THE PROSTHETIC STEM. ON (B)(6) 2020, I HAD A BONE GRAFT TO REPAIR THE FRACTURE. A CLOUDY MILKY YELLOW FLUID ALONG WITH METAL DEBRIS WAS DISCOVERED IN THE HIP JOINT. ALSO, THERE WAS OSTEOLYSIS IN THE PROXIMAL FEMORAL FEMUR. THE ACETABULAR HAD OVERHANGING SCAR TISSUE AND BONE. THE TRUNION HAD STRIPE WEAR INDICATING IMPINGEMENT AND LIKELY SOURCE OF THE METALLOSIS. THE 28 MM FEMORAL HEAD WAS REPLACED WITH A 40MM COCR HEAD. SYMPTOMS OF METALLOSIS CONTINUE. FDA SAFETY REPORT ID# (8)(4). UPDATE: AS PER THE PATIENT, HE HAD A LEFT THA ON (B)(6) 2016. HE STARTED TO EXPERIENCE PAIN AT THE END OF (B)(6) 2016. THE PATIENT HAD A BONE SCAN DON ON (B)(6) 2017 (APPROX.) WHICH INDICATED INFECTION/IMPLANT LOOSENING. NO TREATMENT WAS GIVEN TO THE PATIENT. ON (B)(6) 2017 (APPROX.) HE WAS PLACED ON ORAL ANTIBIOTICS FOR 30 DAYS DUE TO INFECTION. ON (B)(6) 2017 X-RAYS CONFIRMED LOOSENING AND THE PATIENT WAS REV

  Patient problems: Hip Fracture; Inadequate Osseointegration; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 10731085 ↗
• InjurySep 8, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A SURGEON PERFORMED A REVISION OF A PATIENT'S RIGHT HIP AFTER THE PATIENT COMPLAINED OF PAIN. THE SURGEON REPORTED THAT IMPLANT HAD SUBSIDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS.

  Patient problems: Injury; Pain

  MAUDE report 6852625 ↗