Restoration 6276-1-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540641083), received between Oct 5, 2017 and Jul 22, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT MARCH 21, 2022, IT WAS DISCOVERED THROUGH DIAGNOSTIC STUDIES THE FEMORAL STEM WAS BROKEN WHICH RESULTED IN REVISION SURGERY ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799384 ↗
• InjuryMay 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE WAS AN ORDER FOR RESTORATION MODULAR BHA (INCLUDING GRIP PLATE) FROM DEALER ON APRIL 30. IT WAS GOING TO BE USED FOR SUBTROCHANTERIC FRACTURE ON MAY 6. SALES REP COULDN'T HAVE A MEETING DUE TO NATIONAL HOLIDAYS. FRACTURE WAS LATERAL, BUT SURGEON DECIDED TO REMOVE BONE FRAGMENT CONTAINING THE GREATER TROCHANTER AND USE THE STEM. SALES REP TOLD HIM THAT THE PROXIMAL BODY OF THE STEM WAS EXPOSED AND THERE WAS A RISK OF BREAKAGE. HOWEVER, HE INSISTED THAT FRACTURE SIDE IS PARALYZED, AND CARRIED OUT THE OPERATION. SINCE THERE WAS NO GREATER TROCHANTER, NO CALKER, AND NO ROTATION INDEX, VERSION CONTROL DID NOT WORK WELL. ALTHOUGH CONSIDERABLY BACK TWISTED, HE THOUGHT IT WOULD NOT BE DISLOCATED. FROM ASSISTANT'S VIEW, IT WAS ALREADY SUBLUXED.

  Patient problems: Insufficient Information

  MAUDE report 11906905 ↗
• InjurySep 24, 2019Osseointegration Problem; Osseointegration Problem

  PATIENT PRESENTED WITH LYSIS. LOOSE AT THE BODY STEM INTERFACE. REVISION OF CONE CONICAL RESTORATION MODULAR STEM. LEFT THA. UPDATE: "THE REASON FOR REVISION WAS PT PAIN AND LYSIS ON SCANS. THE SURGEON HYPOTHESISED THAT IT MAY HAVE BEEN A LOOSE STEM/ BODY INTERFACE."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 9111368 ↗
• InjuryJun 18, 2018Material Deformation; Material Deformation

  RESTORATION MOD PROXIMAL BODY SHEARED OFF AT THE TRUNNION. AFFECTED IMPLANT WAS REMOVED AND REPLACED WITH APPROPRIATE PROX BODY AND MDM HEAD/INSERT.

  Patient problems: Injury

  MAUDE report 7610530 ↗
• MalfunctionOct 5, 2017Break; Break

  SCREW THAT REINFORCES TAPER BETWEEN RESTORATION MODULAR CONE BODY AND STEM BROKE DURING TIGHTENING. THE TORQUE WRENCH WAS USED AND THE SURGEON WAS INFORMED NOT TO EXCEED 180 IN-LBS. THE SURGEON STATE[D] THAT THE TORQUE WRENCH GAVE WAY AT 180 IN-LBS SO HE CONTINUED TO TIGHTEN. THIS WAS DONE THREE TIMES & SCREW BROKE ON THIRD ATTEMPT. THE TORQUE WRENCH MAY HAVE SLIPPED OFF SCREW WHEN IT REACHED 180 IN-LBS MAKING THE SURGEON BELIEVE THE WRENCH GAVE WAY. THE SCREW WAS OVER-TORQUED BEYOND SAFETY LIMITS. THE SURGEON LEFT STEM IN WITHOUT THE SCREW. THE BODY AND STEM TAPER WAS SECURELY IMPACTED DURING THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916344 ↗