Restoration ADM/MDM X3 InsertRecalls & reported problems across all models

We found 3 models of Restoration ADM/MDM X3 Insert by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2022 and Jul 31, 2026 — classified as 69 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Restoration ADM/MDM X3 Insert problems

Restoration ADM/MDM X3 Insert models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Restoration ADM/MDM X3 Insert 7236-2-848

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  46 reports
• Restoration ADM/MDM X3 Insert 7236-2-852

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  13 reports
• Restoration ADM/MDM X3 Insert 7236-2-854

  Prosthesis, hip, semi-constrained, metal/polymer, uncemented
  10 reports

Recent Restoration ADM/MDM X3 Insert adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED: "PATIENT LEFT HIP REVISED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." AN MDM METAL LINER AND ADM/ MDM POLY INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 24954276 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SUSPECTED INFECTION. ALL IMPLANTS (STRYKER ACETABULUM, COMPETITOR FEMUR) WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 24666991 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 23708779 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT HIP REVISION, PATIENT PRESENTED WITH AN INFECTED SURGICAL SITE. SURGEON SWAPPED THE LINER, INSERT, AND HEAD, AND ALL OTHER COMPONENTS WERE LEFT IN-SITU AT THIS TIME. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 23529256 ↗
• 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 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT REVISED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." ALL IMPLANTS WERE REVISED. REVISED IMPLANTS INCLUDE SCREWS FROM PRIMARY SURGERY AND FIRST REVISION, WHICH HAD BEEN REMOVED AND RE-IMPLANTED IN THE SECOND REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 22434715 ↗
• 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 ↗
• InjuryMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A PRIMARY HIP REPLACEMENT WHERE AN MDM LINER, POLY INSERT, AND 28 CERAMIC HEAD WAS IMPLANTED. UPON FOLLOW UP THE LINER WAS STILL ATTACHED TO THE CUP AND THE HEAD WAS STILL ATTACHED TO THE STEM, BUT THE POLY INSERT HAD DETACHED FROM THE LINER AND HEAD AND WAS DISLODGED IN PATIENT. THE SURGEON PERFORMED A REVISION SURGERY AND REMOVED THE HEAD, LINER AND INSERT. HE REPLACED IT WITH A CONSTRAINED LINER.

  Patient problems: Joint Dislocation

  MAUDE report 22097135 ↗
• InjuryApr 24, 2025Use of Device Problem; Use of Device Problem

  DURING A TOTAL HIP REPLACEMENT, THE WRONG IMPLANT WAS PUT INTO THE PATIENT. THE SURGEON USES OUR MDM IMPLANTS AND THE WRONG SIZE/ALPHA CODE INSERT WAS IMPLANTED. FOR THE PROCEDURE, IT WAS A 50MM D TRIDENT II CLUSTERHOLE CUP IMPLANTED WITH AN ALPHA CODE D MDM LINER. HOWEVER, AN ALPHA CODE E MDM INSERT WAS USED FOR THE PROCEDURE. THE ISSUE WAS IDENTIFIED TOWARDS THE END OF THE PROCEDURE WHEN THE SURGEON CARD WAS BEING MADE BY THE REPRESENTATIVE. THE SURGEON WAS NOTIFIED IMMEDIATELY, BUT THE PATIENT WAS ALREADY BEING AWAKENED. THE PATIENT WAS TAKEN BACK INTO SURGERY TO CORRECT THE SIZING OF THE IMPLANTS THE FOLLOWING MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905166 ↗
• InjuryApr 23, 2025Use of Device Problem; Use of Device Problem

  REVISION (OF COMPETITOR IMPLANTS), LEFT HIP. IT WAS REPORTED THAT AN INCORRECT INSERT WAS IMPLANTED. THE 42E INSERT WHICH WAS IMPLANTED WAS REMOVED THE SAME DAY, AND A 48G INSERT WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896625 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "BOTTOM EDGE OF WOUND STARTED OOZING. THIS WAS REVISION SURGERY. THE PT PRESENTED TO THE EMERGENCY DEPARTMENT WITH AN OOZING WOUND. SHE WAS TAKEN TO THEATRE THAT AFTERNOON FOR A WASHOUT & THE SURGEON DECIDED TO CHANGE THE HEAD & MDM INSERT AS WELL. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN SURGERY. THIS WAS A REVISION PROCEDURE DUE TO EVIDENCE OF A POSSIBLE INFECTION."

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21642343 ↗
• 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 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS EXCEPT THE SHELL AND DISTAL RESTORATION MODULAR STEM WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21545613 ↗

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