Restoration 6276-7-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540643742), received between Mar 8, 2018 and Jan 10, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: REVISION SURGERY OF STEM, (B)(6) 2021 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13205246 ↗
• InjuryAug 30, 2021Fracture; Fracture

  IT HAS BEEN REPORTED "BROKEN CONE CONICAL STEM, 2 YRS AFTER IMPLANTATION."

  Patient problems: Insufficient Information

  MAUDE report 12384651 ↗
• InjuryAug 18, 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: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 12335702 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT ALLEGEDLY HAD SUFFERED INJURIES/COMPLICATIONS FROM A FAILED HIP REPLACEMENT PART. UPDATE BASED ON MED REVIEW:, RIGHT TOTAL HIP REPLACEMENT REVISION WITH FEMORAL CERAMIC HEAD EXCHANGE WITH A SLEEVE, AS WELL AS ACETABULAR COMPONENT REVISION" FOR A DIAGNOSIS OF "FAILED LINER WITH PARTIAL DISLOCATION OF RIGHT TOTAL HIP AND METALOSIS". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A POSTERIOR APPROACH. THE REPORT NOTES, " . LARGE AMOUNT OF HETEROTOPIC BONE POSTERIORLY, EVENTUALLY, ABLE TO DISLOCATE FEMORAL HEAD. REMOVED CERAMIC HEAD. LINER HAD BEEN DISPLACED ANTERIORLY AND DISLOCATED. THIS HAD LED TO METALOSIS, SIGNIFICANT WEAR ON THE CERAMIC HEAD ONTO THE METAL EDGE. POLYETHYLENE DUAL MOBILITY LINER WAS REMOVED WITH SOME EFFORT. METALLIC SLEEVE HAD SOME SCRATCHES. THE RIGHT HIP DEMONSTRATES THREE SCREWS IN THE ACETABULUM, A RESTORATION MODULAR STEM WHICH APPEARS SUBSIDED, AND A SMALLER MODULAR HEAD WHICH APPEARS TO BE SUPERIORLY MIGRATED IN AN MDM LINER.

  Patient problems: Inflammation; Joint Dislocation; Pain

  MAUDE report 12141305 ↗
• InjuryJun 28, 2021Fracture; Fracture

  IT HAS BEEN REPORTED "SPONTANEOUS RUPTURE OF THE PROSTHETIC STEM ON (B)(6) 2021 IN THE ABSENCE OF TRAUMA AND NOT ASSOCIATED WITH BONE LESIONS".

  Patient problems: Insufficient Information

  MAUDE report 12081665 ↗
• InjuryJun 25, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED HIS SUSPICION THAT THE PROXIMAL CONE BODY WAS PROBABLY NOT FULLY SEATED DURING THE PRIMARY IMPLANTATION. THE PROXIMAL CONE BODY, BIOLOX CERAMIC HEAD, AND 36D 0° INSERT WERE REVISED TO A PROXIMAL CONE BODY, LFIT V40 HEAD, SIZE D CONSTRAINED INSERT, AND A DALL-MILES GRIP PLATE WITH CABLES. REP PROVIDED USAGE SHEETS FOR THE PRIMARY AND REVISION SURGERIES, PICTURES OF THE EXPLANTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Laxity

  MAUDE report 10194103 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A STRYKER STEM, BODY, AND HEAD WERE REMOVED FROM A CONSTRUCT WHICH INCLUDED A COMPETITOR'S LINER AND SHELL.

  Patient problems: Injury

  MAUDE report 7323013 ↗