Restoration ADM/MDM X3 Insert 7236-2-854Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327315820), received between Dec 13, 2022 and Mar 23, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY SALE REP THAT THE REVISION SURGERY REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2024 DUE TO PATIENT X-RAY SHOWS DISLOCATED AFTER THE PRIMARY SURGERY. UPDATE: THE ADM X3 DISLOCATED FROM THE MDM METAL LINER. THE SURGICAL TREATMENT FOR THE DISEASE IS STEM REPLACEMENT. THE REVISION SURGERY WAS PERFORMED AND REINSERTED INTO THE PATIENT EXCEPT THE STEM AS THE ORIGINAL STEM SIZE WAS UNABLE TO BE USED.

  Patient problems: Joint Dislocation

  MAUDE report 20510037 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT THA ON (B)(6) 2023. PATIENT DEVELOPED PERIPROSTHETIC JOINT INFECTION AND WAS REVISED ON (B)(6) 2023. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 18795475 ↗
• InjuryJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A COMPETITOR HEAD DISSOCIATING FROM THE ADM/ MDM POLY INSERT. THE HEAD AND INSERT WERE REVISED TO ANOTHER HEAD AND INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 18480988 ↗
• InjuryDec 11, 2023Adverse 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 DRAINAGE. AN I&D WAS PERFORMED, AND A 48G ADM/ MDM POLY INSERT AND COMPETITOR HEAD WERE REVISED FOR THE SAME. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 18299512 ↗
• InjuryNov 24, 2023Adverse 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 DRAINAGE. AN I&D WAS PERFORMED, AND A 48G ADM/ MDM POLY INSERT AND COMPETITOR HEAD WERE REVISED FOR THE SAME. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fluid Discharge

  MAUDE report 18204339 ↗
• InjuryOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION FOR INSTABILITY. BIOLOX HEAD DISASSOCIATED FROM MDM LINER.

  Patient problems: Joint Dislocation

  MAUDE report 17866059 ↗
• InjuryJun 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "WAS NOTICED ON FILM AND INTEROP THAT THE POLY HEAD HAD DISASSOCIATED FROM THE INNER CERAMIC BEARING. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. NEW MDM HEAD CONSTRUCT REIMPLANTED."

  Patient problems: Joint Dislocation

  MAUDE report 17076197 ↗
• InjuryMay 9, 2023Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  AS REPORTED: "THE REVISION ON (B)(6) 2022 WAS OF A RIGHT [COMPETITOR] TOTAL HIP FOR INSTABILITY. THE REVISION TODAY WAS ALSO DUE TO INSTABILITY. IT WAS DISCOVERED THAT THE [COMPETITOR] CERAMIC HEAD HAD DISASSOCIATED FROM THE MDM POLYETHYLENE INSERT. A STRYKER CONSTRAINED LINER AND NEW [COMPETITOR] HEAD WERE IMPLANTED TODAY. NO FURTHER INFORMATION AVAILABLE FROM THE SURGEON OR HOSPITAL.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16898484 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION ON 18/MARCH/2022. THE PATIENT HAD A PRIMARY LEFT THA OUT OF CORS SCOPE. ON (B)(6) 2021 THE PATIENT HAS A PERIPROSTHETIC FRACTURE OF THE FEMUR AND IS ENTERED INTO CORS. THE PATIENT DEVELOPED AN INFECTION OF THE LEFT HIP AND UNDERWENT REVISION FOR PJI WITH ONLY THE MDM & HEAD COMPONENTS EXCHANGED ON (B)(6) 2021. PATIENT DEVELOPS INFECTION AGAIN AND UNDERGOES REVISION ON (B)(6) 2022. ALL COMPONENTS EXCHANGED. PATIENT IS FOLLOWED UP AND RETURNS WITH SIGNS OF INFECTION, UNDERGOES REVISION ON (B)(6) 2022. ONLY MDM & HEAD COMPONENTS EXCHANGED ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15967164 ↗