Restoration 6276-1-119Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540641137), received between Jul 1, 2019 and Dec 11, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS (INCLUDING COMPETITOR ACETABULAR COMPONENTS) WERE REMOVED AND A SPACER WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 20902211 ↗
• InjuryMay 13, 2022Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED: "CONE BODY RESTORATION CONICAL TO MOVE POST OPERATION IN RETROVERSION."

  Patient problems: Insufficient Information

  MAUDE report 14389793 ↗
• InjuryDec 22, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT HAD RIGHT TOTAL HIP REPLACEMENT OUTSIDE HOSPITAL (B)(6) 2011. AFTER THE HIP REPLACEMENT, PATIENT PRESENTED WITH INSTABILITY FAILURE, THEN UNDERWENT REVISION WITH REMAINING CUP, OTHER COMPONENTS EXCHANGED (B)(6) 2018. BECAUSE OF EXTENSIVE SOFT TISSUE DESTRUCTION THAT LED PATIENT PRESENTING SYMPTOM OF INSTABILITY, PATIENT UNDERWENT RIGHT TOTAL HIP REVISION LINER, HEAD, AND PROXIMAL RMS (BODY) COMPONENTS EXCHANGED ON (B)(6) 2019. THE PATIENT CONTINUES WITH INSTABILITY AND HAS A SECOND REVISION ON (B)(6) 2020 WHERE THE HEAD AND THE BODY OF THE RMS ARE EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11056659 ↗
• InjuryOct 17, 2019Unstable; Unstable

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2019. PROCEDURE: THE PATIENT HAD RIGHT TOTAL HIP REPLACEMENT OUTSIDE HOSPITAL (B)(6) 2011. AFTER THE HIP REPLACEMENT, PATIENT PRESENTED WITH INSTABILITY FAILURE, THEN UNDERWENT REVISION WITH REMAINING CUP, OTHER COMPONENTS EXCHANGED (B)(6) 2018. BECAUSE OF EXTENSIVE SOFT TISSUE DESTRUCTION THAT LED PATIENT PRESENTING SYMPTOM OF INSTABILITY, PATIENT UNDERWENT RIGHT TOTAL HIP REVISION LINER, HEAD, AND PROXIMAL RMS (BODY) COMPONENTS EXCHANGED ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9202457 ↗
• InjuryJul 1, 2019Malposition of Device; Malposition of Device

  REP REPORTED THROUGH A FAX THAT PATIENT DISLOCATED THEIR RIGHT HIP. OPEN REDUCTION OF HIP, CHANGED ADM LINER AND FEMORAL HEAD. UPDATE 04 JUNE, 2019: OPERATIVE REPORT STATES "IT WAS FOUND THAT THE PROXIMAL BODY WAS PLACED IN SIGNIFICANT ANTEVERSION, SO THEN IF THE PATIENT CAME IN EXTENSION IT WOULD LEVER OUT ANTERIORLY".

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8750320 ↗