Restoration 6276-7-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540643735), received between Jun 14, 2018 and Mar 31, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2025Fracture; Fracture

  PATIENT REPORTED THAT THEY HAD A SECOND REVISION WITH STRYKER IMPLANTS ON (B)(6) 2024 FOR PAIN. THEY FURTHER STATED THAT IT WAS NOTED DURING THE PROCEDURE THAT THE TIP OF THE PROSTHETIC IN THE FEMUR HAD BROKEN OFF AND COME LOOSE. THE BROKEN PIECE AT THE VERY DISTAL END OF THE FEMORAL COMPONENT WAS LEFT IN THE PATIENT, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21730307 ↗
• InjuryMar 18, 2025Fracture; Fracture

  IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2014, HE UNDERWENT REVISION SURGERY AND WAS IMPLANTED WITH A RESTORATION MODULAR HIP SYSTEM. IN LATE ON (B)(6) 2024 HE STARTED TO EXPERIENCE EXTREME PAIN IN HIS RIGHT UPPER LEG FEMUR AREA AND HAD DIFFICULTY STANDING OR WALKING. HE WAS REVISED ON (B)(6) 2024, ALLEGEDLY DUE TO THE TIP OF THE PROSTHESIS BROKE OFF INSIDE HIS FEMUR.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 21631315 ↗
• InjuryJan 7, 2025Fracture; Fracture

  HIP REVISION SURGERY WAS REQUIRED DUE TO FRACTURE OF THE ROD IMPLANTED IN PRIMARY SURGERY. THERE WERE NO ADVERSE EVENTS IN THE REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21089637 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX RIGHT THA ON (B)(6) 2022. THE PATIENT DEVELOPS PJI REQUIRING A RIGHT THA REVISION ON (B)(6) 2022. ALL COMPONENTS WERE EXCHANGED. REPORTED AS CORS PER 11001HIP. THE PATIENT REQUIRES A SECOND RIGHT THA REVISION DUE TO PERSISTENT PJI. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 16936894 ↗
• InjuryJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE RESTORATION MODULAR DISTAL STEM BREAKING IN THE MIDDLE OF THE DISTAL STEM. SURGEON REPORTED A POSSIBLE CONTRIBUTING FACTOR BEING THE SELECTED STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY (INCORRECT SELECTION, NOT INCORRECT SIZE). THE MODULAR STEM AND FEMORAL HEAD WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD OR PROXIMAL BODY.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13222533 ↗
• InjuryNov 4, 2020Fracture; Fracture

  RESTORATION MODULAR BROKEN STEM REQUIRING SURGERY. IN SURGERY ETO WAS REQUIRED TO GET STEM OUT. UPDATE: "GUN SHOT IN (B)(6) THAT REQUIRED A THA. HAD SEVERAL SURGERIES INCLUDING A 2 STAGE REVISION FOR INFECTION. CURRENTLY HAS STABLE LABS AND NO INFECTION AT TIME OF SURGERY. STEM IS BROKEN ABOUT 1.5¿ DOWN FROM THE BODY. LEFT HIP".

  Patient problems: Failure of Implant; Insufficient Information; No Information

  MAUDE report 10786964 ↗
• InjuryOct 23, 2020Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY SCRUB TECHNICIAN THAT REVISION SURGERY PERFORMED DUE TO PATIENT FEEL PAIN IN THE HIP FOR A WHILE AFTER HAVING HIP RECONSTRUCTION SURGERY LONG TIME AGO, AFTER X-RAY, X-RAY FILM REVEALED THAT HIP COMPONENT WAS LOOSE. (STRYKER STAFF AWARENESS DATE IS THE REVISION SURGERY AS EXACT PRIMARY DEVICE TYPE IS UNKNOWN).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10725267 ↗
• InjuryApr 1, 2019Break; Break

  REVISION OF BROKEN RESMOD STEM. UPDATE PER SALES REP: "THE DISTAL STEM WAS BROKEN APPROXIMATELY 1/3 FROM THE END, THE BODY AND JUNCTION WERE NOT INVOLVED." RIGHT SIDE.

  Patient problems: Injury

  MAUDE report 8470312 ↗
• InjuryJun 14, 2018Crack; Fracture; Loss of Osseointegration; Crack; Fracture; Loss of Osseointegration

  FAILED REVISION TOTAL HIP. PATIENT WAS BEING WATCHED FOR LOOSE STEM BY SURGEON AND WAS PLANNING ON REVISION UPON RETIREMENT. DUE TO STEM FAILURE REVISION WAS NECESSARY AT THIS TIME BY A DIFFERENT SURGEON.

  Patient problems: Injury

  MAUDE report 7602934 ↗