Restoration 6276-1-221Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540641212), received between Jan 12, 2018 and May 9, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  THIS REPORT IS FOR THE (B)(6) 2022 REVISION. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2022 THE, REP CONFIRMED THAT ON (B)(6) 2022 THE HIP HAD BEEN REVISED AS WELL. AN MDM METAL LINER, ADM/ MDM POLY INSERT, FEMORAL HEAD, AND RESTORATION MODULAR PROXIMAL BODY WERE REVISED TO ANOTHER PROXIMAL BODY AND HEAD, AND A CONSTRAINED INSERT. UPDATE REASON FOR REVISION: "LEG LENGTH INEQUALITY AND INSTABILITY WITH HISTORY OF DISLOCATION. MDM HEAD DISLOCATION OUT OF MDM LINER."

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Unequal Limb Length

  MAUDE report 14342958 ↗
• InjuryAug 17, 2021Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  PATIENT IS A 57-YEAR-OLD FEMALE WHO PREVIOUSLY UNDERWENT RIGHT TOTAL HIP REPLACEMENT - OUTSIDE CORS SCOPE (GERMANY IN 2008). SHE UNDERWENT ACETABULAR REVISION - OUTSIDE CORS SCOPE (ROI 2011). PATIENT FELL AND HAD A PPFX OF HER RIGHT FEMUR (B2) UNDERWENT REVISION IN (B)(6) 2020. PATIENT DISLOCATED IN BED AND REQUIRED REVISION DUE TO INSTABILITY AND SUBSIDENCE OF FEMORAL COMPONENT PERFORMED IN (B)(6) 2020. MDM POLYETHYLENE, HEAD, AND RMS COMPONENTS EXCHANGED.

  Patient problems: Joint Dislocation

  MAUDE report 12334692 ↗
• InjuryDec 23, 2019Material Erosion; Material Erosion

  IT WAS REPORTED THAT DURING REVISION OF RESTORATION MODULAR PROXIMAL BODY, THE HEAD AND TRUNNION EXHIBITED TRUNNIONOSIS.

  Patient problems: Injury

  MAUDE report 9512723 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO POSSIBLE TRUNNIONOSIS. THE ORIGINAL CASE TOOK PLACE IN 2008.

  Patient problems: Injury

  MAUDE report 8731816 ↗
• InjuryFeb 21, 2019Unstable; Unstable

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT HIP DUE TO INSTABILITY. IN REPORTING AN INTRA-OPERATIVE INSTRUMENT BREAKAGE, REP MENTIONED REVISED DEVICES. SPOKE TO REP. PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. SURGEON DID NOT REPORT ANY POSSIBLE CAUSE OR CONTRIBUTOR TO INSTABILITY. INTRA-OPERATIVELY, NOTHING WAS FOUND LOOSE, WORN, OR BROKEN. A 21 +20 RESTORATION MODULAR CONE BODY, SIZE 40 METAL HEAD, AND 40E POLY LINER WERE REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury

  MAUDE report 8358936 ↗
• InjuryDec 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "PATIENT APPEARED TO HAVE OFFSET ISSUES ON X-RAY". A 21MM +20 V40 RESTORATION PROXIMAL BODY AND 36 +0 BIOLOX V40 HEAD WERE REVISED TO A 25MM +20 V40 RESTORATION PROXIMAL BODY AND ANOTHER 36 +0 BIOLOX V40 HEAD.

  Patient problems: Injury

  MAUDE report 8156282 ↗
• InjuryJan 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. EXPLANTED DEVICES ARE UHR UNIVERSAL HEAD, CONE BODY, AND LFIT V40 FEMORAL HEAD (BOTH IMPLANTED (B)(6) 2017). INITIAL SURGERY (B)(6)2017 WAS PERFORMED DUE TO A FAILED COMPETITOR IM HIP NAIL. 1ST AND 2ND REVISION WAS DUE TO NON-COMPLIANT PATIENT VS HIP INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 7186658 ↗