Restoration 6276-1-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540641168), received between Aug 16, 2017 and Jun 6, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158864 ↗
• InjuryMay 19, 2025Fracture; Fracture

  REVISION HIP OF AN ACCOLADE II (IMPLANTED IN 2020) DUE TO SUBSIDENCE REVISED TO RESTORATION MODULAR STEM. DURING SURGEON TIGHTENING OF PROXIMAL CONICAL BODY WITH 5MM HEX THE SCREW SNAPPED AT ~5MM DISTAL END OF SCREW THREAD. SURGEON RETRIEVED SNAPPED END OF SCREW FROM PATIENT. PROXIMAL CONE BODY RE-IMPLANTED AND NEW PROXIMAL CONE BODY SCREW TIGHTENED WITH HEX SCREW AND TORQUE WRENCH WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22042705 ↗
• InjuryJul 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE ADM/ MDM POLY INSERT FROM THE MDM LINER. THE POLY INSERT, CERAMIC HEAD, AND CONE BODY WERE REVISED. REP CONFIRMED THE REASON FOR CONE BODY REVISION WAS TO IMPLANT A LONGER PROXIMAL BODY. REP ALSO CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED CERAMIC HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10288221 ↗
• InjuryDec 19, 2018Inadequacy of Device Shape and/or Size; Device Slipped; Loosening of Implant Not Related to Bone-Ingrowth; Inadequacy of Device Shape and/or Size; Device Slipped; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED BECAUSE THE PROXIMAL BODY OF THE STEM SLIPPED (ROTATED) 180° DUE TO THE LACK OF A LOCKING SCREW. REP DID NOT REPORT DISLOCATION OR DISASSOCIATION. A 25 +10 PROXIMAL BODY, 28 +8 LFIT V40 HEAD, 42E ADM INSERT AND 42E MDM LINER WERE EXPLANTED AND A GIRDLESTONE PROCEDURE WAS PERFORMED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury

  MAUDE report 8183212 ↗
• MalfunctionAug 16, 2017Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT THE SURGEON WAS IMPLANTING A RESTORATION CONE CONICAL. THE WHOLE CONSTRUCT (CONE AND STEM) HAD BEEN IMPLANTED AND AS THE SURGEON STARTED TO TIGHTEN, THE BOLT SHEARED AND SNAPPED. NO UNINTENDED METAL FELL INTO OR WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED BY REMOVING THE CONSTRUCT AND REPLACING IT WITH A NEW ONE OF THE SAME SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6797815 ↗