Restoration 6276-7-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540643728), received between Mar 7, 2017 and Apr 16, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2024Fracture; Fracture

  THE FOLLOWING WAS REPORTED: "LAST THURSDAY (B)(6)2024, THE PATIENT WAS TRANSFERRED TO US FROM THE CHRISTLICHES KLINIKUM UNNA WITH A PERIPROSTHETIC FRACTURE WITH IMPLANT FRACTURE, WHICH WE OPERATED ON FRIDAY (B)(6) 2024. THE PATIENT STATED THAT SHE HAD BEEN EXPERIENCING INCREASED MUSCLE PAIN IN HER RIGHT LEG SINCE (B)(6)MARCH 2024. HOWEVER, SHE COULD NOT RECALL ANY TRAUMA OR INCIDENT OF ANY KIND. SHE SAID IT GOT PROGRESSIVELY WORSE. IT WAS DIAGNOSED RADIOLOGICALLY ON THE PREADMISSION DAY FOR TREATMENT OF THE LEFT COXARTHROSIS."

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19122538 ↗
• InjuryFeb 7, 2024Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  STEM FRACTURE (MATERIAL FAILURE) OF THE INSERTED REVISION THA (STRYKER: RESTORATION MODULAR HIP SYSTEM STEM 155MM/14MM, V40 19MM/+0, BIOLOX DELTA CERAMIC V40 HEAD 36MM/-5MM) AFTER IMPLANTATION OF THE STEM AS PART OF A STEM REPLACEMENT (B)(6). COMPLAINTS TRIGGERED BY A TURNING MOVEMENT IN BED 2 DAYS EARLIER, DIFFERENTIAL DIAGNOSIS DUE TO STUMBLING WITHOUT FALLING 1 WEEK EARLIER

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Insufficient Information; Unspecified Infection

  MAUDE report 18659230 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT OCCURRED DURING CONVERSION OF A FEMORAL NAIL TO A LEFT HEMI HIP. WHEN IMPACTING THE CONE BODY ON TO THE DISTAL STEM, THE PATIENT'S FEMUR FRACTURED. THE STEM CONSTRUCT WAS IMPLANTED AND TWO CABLE AND SLEEVE SETS WERE ADDED. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES.

  Patient problems: Bone Fracture(s)

  MAUDE report 17114798 ↗
• 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 14389786 ↗
• InjuryMay 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE RESTORATION MODULAR STEM CONSTRUCT BREAKING AT THE JUNCTION OF THE DISTAL AND MEDIAL COMPONENTS. THE STEM CONSTRUCT, HEAD, AND LINER WERE REVISED. REP PROVIDED AN X-RAY AND A 2015 OPERATIVE REPORT AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11771147 ↗
• MalfunctionMar 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING IMPLANTATION ALLEGEDLY THE FEMORAL SCREW PROXIMAL BODY WOULD NOT ENGAGE WITH THE TAPER. NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6383702 ↗