Restoration ADM/MDM X3 Insert 7236-2-852Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327315967), received between May 26, 2023 and Jul 31, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Device Dislodged or Dislocated

  It was reported that the patient's Left hip was revised. After a history of multiple dislocations, a competitor hip was revised with Stryker acetabular components and competitor head and sleeve. Patient dislocated again, and surgeon noted a pelvic fracture (also noting patient has poor bone quality). All implants were removed and a Girdlestone procedure was performed. Rep confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 50102143 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI CAPTURES THE 2ND REVISION DUE TO INCORRECT INSERT ON (B)(6) 2026. REVISION DUE TO INCORRECT INSERT (F, INSTEAD OF E) BEING PUT ON AN MDM WASH OUT. SURGEON PICKED UP ON X-RAY BUT COULDN'T FIGURE OUT WHAT WAS WRONG. SENT TO REP TO HELP DIAGNOSE PROBLEM. ONCE IT WAS FIGURED OUT, REVISION SURGERY WAS SCHEDULED. SHORT PROCEDURE, NO POLY WEAR ON INSERT. TRIALED HEAD & INSERT TO MAKE SURE TISSUE TENSION WAS ADEQUATE, AND THEN PUT CORRECT IMPLANTS IN. REVISION 2 DONE ON (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 25308738 ↗
• InjuryNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAD A HIP REPLACEMENT, FELL AND DISLOCATED HER HIP THE NEXT DAY. HAD A CLOSED REDUCTION. HIP REMAINED UNSTABLE. THE HIP WAS REVISED THE DAY AFTER. DURING THE REVISION IT WAS FOUND THAT THE MDM POLY INSERT DISASSOCIATED FROM THE 28 HEAD. WE REPLACED THE HEAD AND INSERT AND FOUND THE HIP WAS STABLE. THEY ARE SPECULATING THAT DURING THE CLOSED REDUCTION THE INSERT WAS LEVERED OFF OF THE HEAD.

  Patient problems: Insufficient Information

  MAUDE report 23479185 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT INDICATED HE WAS UNSATISFIED WITH HIS RIGHT HIP REPLACEMENT DURING A ONE-YEAR CLINIC EVALUATION ON (B)(6) 2024 ON A PATIENT REPORTED OUTCOME FORM. HE ALSO RATED PAIN AS 6/10. THE PI ASSESSED HIS COMPLAINTS OF RIGHT HIP PAIN AND OPINED IT GENERATED FROM THE LUMBAR SPINE.

  Patient problems: Pain

  MAUDE report 22174255 ↗
• InjuryMar 13, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO NEW INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 21593119 ↗
• InjuryFeb 26, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER THE FOLLOWING SERIES OF EVENTS: PATIENT FELL 4 DAYS POST-OP AND DISLOCATED. A CLOSED REDUCTION WAS PERFORMED. AN X-RAY TAKEN AFTER THE CLOSED REDUCTION DIDN'T 'LOOK RIGHT,' AND AN OPEN REDUCTION WAS PERFORMED. IT WAS OBSERVED THAT THE POLY INSERT WAS FLOATING IN THE JOINT - IT WAS OFF OF THE FEMORAL HEAD AND OUT OF THE METAL LINER (IT IS NOT KNOWN WHICH SEPARATION OCCURRED FIRST). A NEW FEMORAL HEAD AND ADM/ MDM POLY INSERT WERE IMPLANTED. THE ORIGINAL POLY AND FEMORAL HEAD WERE RE-ASSEMBLED AT THE BACK TABLE TO DEMONSTRATE TO THE SURGEON THE FORCE NEEDED TO ASSEMBLE THE IMPLANTS. THE REP PROVIDED PICTURES SHOWING THE POLY INSERT BEING DISLOCATED AND DISSOCIATED. THE SURGEON WOULD LIKE THIS EVENT AND DEVICES INVESTIGATED, AND WOULD LIKE THE INVESTIGATION RESULTS. THE DEVICES ARE AVAILABLE FOR RETURN, AND THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 21467585 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATION OF HIP, SURGEON HAS REQUESTED THE FEMORAL HEAD BE CHECKED IF IT IS INDEED A +4 HEAD OFFSET. MDM IMPLANTS USED WITH EXETER TRIDENT.

  Patient problems: Joint Dislocation

  MAUDE report 21252115 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HIP REVISION WAS SECONDARY TO INFECTION. THE JOINT WAS OPENED, THE LINER, INSERT, A 15MM SCREW AND THE COMPETITOR HEAD WERE ALL REMOVED. THE WOUND WAS WASHED OUT AND A NEW INSERT, LINER AND COMPETITOR HEAD WERE PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 18937326 ↗
• InjuryDec 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WITH MDM INSERT DISLOCATED AT HOME APPROX 2 MONTHS POST OP AND HAD TO HAVE HIS HIP REVISED. UPDATE AS PER SALES REP: THE HEAD CAME DISLOCATED (DISASSOCIATED) FROM THE POLY. IT WAS STILL ON THE STEM. THERE WAS A FALL INVOLVED. RIGHT SIDE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18339950 ↗
• InjurySep 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "PLEASE FIND ATTACHED INFORMATION FROM INDEX AND REVISION SURGERIES OF A RIGHT TOTAL HIP. THE REVISION WAS SECONDARY TO DISLOCATION. IT WAS DISCOVERED THAT THE CERAMIC HEAD DISASSOCIATED FROM THE POLY INSERT. ALSO DISCOVERED WAS A CRACK IN THE ACETABULUM AND THE APPEARANCE THAT THE CUP HAD MOVED. IT WAS ALSO DETERMINED THAT THE STEM WAS LOOSE. ALL IMPLANTS WERE REMOVED. A MULTIHOLE CUP WAS IMPLANTED WITH MULTIPLE SCREWS AND AN MDM LINER. THE FEMUR WAS PREPARED FOR AN INSIGNIA STEM AND TRIALED. THE HIP REMAINED GROSSLY UNSTABLE SO IT WAS DECIDED TO LEAVE THE PATIENT WITH A GIRDLESTONE. THE PLAN BEING TO COME BACK AFTER THE CUP HAS HEALED AND PLACE A REST MOD WITH CONSTRAINED LINER. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Dislocation

  MAUDE report 17735200 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INDEX LEFT THAT ON (B)(6) 2022. PATIENT WAS DIAGNOSED WITH PJI. PATIENT UNDERWENT REVISION ON (B)(6) 2022. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 17505257 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. PRESENTED WITH AN INFECTED LEFT-HIP AS WELL AS COMPLAINTS OF MULTIPLE HIP DISLOCATIONS (HEAD FROM LINER). DR. OPTED TO REVISE THE PT'S HIP TO AN EXETER STEM USING ANTIBIOTIC-AUGMENTED CEMENT AND REVISED THE PT'S SHELL TO ALLOW FOR A CONSTRAINED LINER AND LONGER HEAD/NECK LENGTH OPTIONS (STEM AND DISTAL SPACER IMPLANTED (B)(6) 2022, REMAINING IMPLANTS IMPLANTED (B)(6) 2023). NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES. NO FURTHER INFO AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17368695 ↗
• InjuryMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  RIGHT TOTAL HIP REVISION/ DISLOCATION OF HIP JOINT / MDM POLY HEAD DISASSOCIATED FROM INNER DELTA V/40 HEAD / PATIENT FELL (PER. SURGEON). ADDITIONAL INFORMATION: THE SALES REP NOTED THAT THE SURGEON EXPLANTED THE SCREW AND REPOSITIONED THE SHELL. A NEW SCREW WAS USED.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 17008919 ↗