Restoration 6276-1-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540641151), received between Nov 29, 2018 and Nov 15, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2021Fracture; Unintended Movement; Fracture; Unintended Movement

  PATIENT HAD RIGHT INDEX THA (OUTSIDE OF CORS SCOPE). PATIENT FELT AND HAD A FEMUR PPFX (B2) UNDERWENT REVISION ON (B)(6) 2019. ONLY FEMUR AND HEAD EXCHANGED. PATIENT RETURNS WITH PAIN AND AN ADDITIONAL FEMORAL (B2) PPFX AND SUBSIDENCE OF FEMORAL COMPONENT. UNDERGOES REVISION ON (B)(6) 2021. FEMUR, HEAD, AND LINER ARE EXCHANGED.

  Patient problems: Bone Fracture(s)

  MAUDE report 12813333 ↗
• InjuryAug 19, 2021Corroded; Corroded

  IT WAS REPORTED BY PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ON (B)(6) 2010 THE PATIENT UNDERWENT A RIGHT HIP SURGERY AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND RESTORATION MODULAR HIP SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT TOTAL HIP REVISION DUE TO CORROSION AND ADVERSE TISSUE REACTION, OSTEOLYSIS OF THE RIGHT TOTAL HIP REPLACEMENT AND A LARGE PSEUDOTUMOR.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 12344544 ↗
• InjurySep 23, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2010 AND WAS REVISED ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9105192 ↗
• InjuryApr 2, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2016. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction; Unspecified Infection

  MAUDE report 8473406 ↗
• MalfunctionDec 7, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A HIP REVISION, THE 23MM +10 RESTORATION MODULAR PROXIMAL BODY WOULD NOT LOCK ONTO THE 17X195 DISTAL STEM. THE PROXIMAL BODY WAS REMOVED AND THE DISTAL STEM WAS FOUND TO HAVE MIGRATED DEEPER INTO THE PATIENT'S FEMORAL CANAL. SURGEON REAMED THE PATIENT'S FEMUR FOR A LARGER SIZE AND IMPLANTED A 20X195 DISTAL STEM WITH A 21MM +10 RESTORATION MODULAR PROXIMAL BODY WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8141371 ↗
• MalfunctionNov 29, 2018Mechanical Problem; Mechanical Problem

  DURING A REVISION OF PATIENT'S LEFT HIP, THE PROXIMAL LOCKING SCREW OF THE 23 +10 PROXIMAL BODY WOULD NOT STAY IN THE PROXIMAL BODY BECAUSE THE RECEIVING HOLE WAS STRIPPED. A 25 +10 PROXIMAL BODY WAS IMPLANTED WITH NO PROXIMAL LOCKING SCREW INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117142 ↗