Restoration 6276-1-127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540641175), received between Sep 11, 2018 and Oct 23, 2020 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2020Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration

  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# (B)(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 10731082 ↗
• InjuryNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, THE RING ON THE COMPETITOR CONSTRAINED LINER WAS FOUND BROKEN. NO TRAUMA WAS REPORTED TO THE REP. THE PROXIMAL STEM BODY AND METAL HEAD WERE REVISED TO A STRYKER PROXIMAL STEM BODY, FEMORAL HEAD, AND LINER.

  Patient problems: Injury

  MAUDE report 8055768 ↗
• InjurySep 11, 2018Migration; Migration

  OPERATIVE SIDE: RIGHT. THE PROXIMAL CONE BODY IMPLANT WAS NOT FULLY SEATED FROM THE (B)(6) /2018 SURGERY. DOCTOR REMOVED THE LOOSE CONE BODY AND PREPARED FOR A REPLACEMENT CONE BODY. REMOVED IMPLANTS: 1. CONE BODY, 2. BIOLOX HEAD. REP CONFIRMED THAT THE DISTAL STEM WAS NOT ACTUALLY REVISED AND REMAINS IMPLANTED.

  Patient problems: Injury

  MAUDE report 7864712 ↗