Restoration 6276-1-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540641090), received between Jan 14, 2015 and Aug 18, 2025 — classified as 6 injuries.

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

• InjuryAug 18, 2025Fracture; Fracture

  NO NEW INFORMATION.

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

  MAUDE report 22834516 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON ADVISED IN THE SCRUB BAY THAT THE 'REVISION FROM THURSDAY WAS INFECTED'. WE HAD TAKEN SWABS DURING HIS REVISION SURGERY AND THEY HAD GROWN CULTURES. DOCTOR TELLS ME WE ARE NO LONGER DOING THIS PATIENTS SUBSEQUENT REVISION HIP REPLACEMENT. THE PLAN IS NOW TO MANAGE WITH ANTIBIOTICS AND NOT REVISE.

  Patient problems: Unspecified Infection

  MAUDE report 21890169 ↗
• InjuryNov 26, 2024Corroded; Degraded; Corroded; Degraded

  IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD. SUBSEQUENTLY HE DEVELOPED PAIN IN HIS GROIN, LATERAL HIP AND BUTTOCKS WITH ANY MOTION AND FELT HE WAS GETTING WEAK AND GETTING WORSE. ALLEGEDLY HIS COBALT CHROME LEVELS WERE NOT SIGNIFICANTLY ELEVATED BUT MRI WAS CONCERNING FOR POSSIBLE ADVERSE LOCAL TISSUE REACTION. HE WAS REVISED ON (B)(6) 2021 FOR ALLEGED TRUNNIONOSIS AND HEAD/TAPER CORROSION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 20784923 ↗
• InjuryMar 3, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE HEAD BREAKING OFF THE TRUNNION. PATIENT IS ACTIVE AND INVOLVED WITH MANUAL LABOR. A FEMORAL HEAD AND RESTORATION MODULAR PROXIMAL BODY WERE REVISED. DUE TO INTRA-OPERATIVE DAMAGE TO THE STEM/ NECK JUNCTION, THE RESTORATION MODULAR DISTAL STEM WAS ALSO REVISED, ADDING 60 TO 90 MINUTES TO THE PROCEDURE (INTRA-OP EVENT REPORTED). REP CAN PROVIDE ADDITIONAL PICTURES AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 11/FEBRUARY/2021 WG: THE REP IS UNAWARE IF THE SHELL OR LINER, WHICH ARE COMPETITOR DEVICES, WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11405370 ↗
• InjuryNov 15, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISSOCIATION OF THE CONSTRAINED LINER FROM THE SHELL. SURGEON REPORTED THAT DUE TO IMPINGEMENT WITH THE STEM, THE LINER WAS LEVERED OUT OF THE SHELL. ALSO, THE SHELL WAS IN A NEUTRAL POSITION. A SHELL AND 2 SCREWS (IMPLANTED IN 2011), RESTORATION MODULAR PROXIMAL BODY (IMPLANTED IN 2013), LFIT FEMORAL HEAD AND CONSTRAINED LINER (BOTH IMPLANTED IN 2019) WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. CORRECTION (B)(6) 2021 WG: IN REPORTING A 5TH REVISION ON (B)(6) /2021 FOR THIS PATIENT'S LEFT HIP, REP CORRECTED INFORMATION FOR THE PATIENT'S PREVIOUS REVISION (THIS PI). A CONSTRAINED LINER AND FEMORAL HEAD WERE THE ONLY DEVICES REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10841562 ↗
• InjuryJan 14, 2015Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS BROUGHT TO OR DUE TO TIP OF THE GREATER TROCHANTER BROKE OFF ON A LEFT HIP. SURGEON SUPPORTED THAT WITH CABLES AND A PLATE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 4416295 ↗