Restoration 6276-1-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540641076), received between Oct 31, 2017 and May 4, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 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 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE INTRA-OPERATIVE FRACTURE DURING A REVISION PROCEDURE ON (B)(6) 2015. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT HIP ON (B)(6) 2021, AN OPERATIVE REPORT FOR 16/NOVEMBER/2015 WAS PROVIDED WHICH NOTES: "...UNDERWENT REVISION OF HIS...HIP REPLACEMENT IN (B)(6) 2015. HE HAS DEVELOPED SIGNIFICANT PAIN WHICH SEEMS TO BE ASSOCIATED WITH A TROCHANTERIC PLATE AND CABLES IMPLANTED TO TREAT AN INTRAOPERATIVE PROXIMAL FEMUR FRACTURE...THE FRACTURE DID NOT DISPLACE AND APPEARS TO HAVE HEALED..." SPOKE TO THE REP WHO WAS PRESENT FOR THE (B)(6) 2015 REVISION. THE REP WAS NOT INFORMED OF AN INTRA-OPERATIVE FRACTURE AND WASN'T AWARE IF THE ADDITIONAL HARDWARE WAS BEING PLACED PROPHYLACTICALLY. FURTHERMORE, THE REP CONFIRMED HE WAS NOT PRESENT FOR THE PROCEDURE TO REMOVE THE PLATE AND CABLES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11771154 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. A 21 +0 RESTORATION MODULAR CONE BODY AND 36 +5 BIOLOX V40 HEAD WERE REVISED TO A 25 +0 BODY AND NEW FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10725266 ↗
• MalfunctionMar 18, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  RESTORATION STEM NOT LOCKED BY SCREW. IT WAS NOTICE WHEN SURGEON TRIED TO ASSEMBLE THE IMPLANT BY THE SCREW BUT SCREW COULD NOT LOCKED. USED ANOTHER IMPLANT. UPDATE: "SIDE OPERATED-RIGHT SIDE HIP SURGERY DELAY WAS 15 MINUTES PATIENT HAVING NAIL EARLIER AND OUR RESTORATION STEM WAS USED FOR REVISION IN THIS CASE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9849837 ↗
• InjuryFeb 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FEMORAL FRACTURE OF HER LEFT HIP. NO DEVICES WERE REVISED, BUT A CABLED GRIP PLATE AND 3 SETS OF CABLES AND SLEEVES WERE IMPLANTED. REP PROVIDED USAGE INFORMATION AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9711667 ↗
• InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  TRITANIUM PRIMARY CLUSTER CUP REVISED FOR LOOSENING ON (B)(6) 2020. THOUGH FOUR SCREWS WERE LISTED IN THE ORIGINAL USAGE REPORT, IT WAS NOT NOTED WHICH WERE WASTED. TWO SCREWS WERE IN THE PATIENT AT TIME OF REVISION--BOTH REMOVED, ONE BROKEN. RESTORATION MODULAR BODY WAS ALSO EXCHANGED AT TIME OF REVISION. PATIENT'S RIGHT HIP WAS REVISED TO COMPETITOR (ACETABULAR) AND STRYKER (FEMORAL) DEVICES. UPDATE PER RESPONSE: "NO ALLEGATIONS WERE MADE AGAINST ANY IMPLANTS OTHER THAN THE CUP."

  Patient problems: Injury

  MAUDE report 9696469 ↗
• InjuryMar 14, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION AND ELEVATED ION LEVELS AS WELL AS SUSPECTED TRUNNIONOSIS. A 36 +5 METAL HEAD AND RESTORATION MODULAR STEM CONSTRUCT WERE REVISED. REP PROVIDED AN X-RAY, PRIMARY OPERATIVE REPORT, PRIMARY IMPLANT SHEET, AND EXPLANT PICTURE, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 8420901 ↗
• InjuryOct 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAS HAD PREVIOUS HIP SURGERIES, ONE PARTICULAR, IN (B)(6) WITH STYKER PRODUCTS. PATIENT COMPLAINED THAT THE IMPLANT MADE HER ILL. FINAL REPORT ON INDICATION FOR SURGERY IDENTIFIES THE FOLLOWING: RIGHT HIP. PATIENT FACTOR: EHLERS-DANLOS SYNDROME. DIFFICULTY WITH RANGE OF MOTION. IMPINGEMENT POSTERIORLY. INCREASING METAL IONS ON SERUM TESTING. WEAKNESS. REVISION RIGHT TOTAL HIP ARTHROPLASTY, ACETABULAR COMPONENT, FEMORAL COMPONENT.

  Patient problems: Inflammation; Injury; Loss of Range of Motion; Reaction

  MAUDE report 6991529 ↗