Restoration ADM/MDM X3 Insert 7236-2-848Recalls & reported problems
Howmedica Osteonics Corp. · Restoration ADM/MDM X3 Insert · Class 2 · Implant
All models of Restoration ADM/MDM X3 Insert (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Howmedica Osteonics Restoration ADM/MDM X3 Insert is a plastic liner used in hip replacement surgery. The 46 reports mostly describe revision operations — the insert coming loose or dislocating, components coming apart, infection at the surgical site, and in a couple of cases an insert of the wrong size being placed during surgery. All 46 reports involve injuries, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 46
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 07613327315974), received between Dec 6, 2022 and Apr 22, 2026 — classified as 46 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, 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information25
- Adverse Event Without Identified Device or Use Problem9
- Detachment of Device or Device Component7
- Device Dislodged or Dislocated5
- Use of Device Problem2
- Noise, Audible1
- Unstable1
Patient problems
- Insufficient Information30
- Unspecified Infection9
- Joint Dislocation7
- No Clinical Signs, Symptoms or Conditions2
- Pain1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 ↗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 ↗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 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 ↗InjuryNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: "PATIENT WAS REVISED DUE TO COMPETITOR HEAD DISASSOCIATING FROM STRYKER MDM HEAD. PATIENT WAS REVISED WITH A NEW COMPETITOR PROXIMAL BODY, AND NEW HEAD AND LINER FROM STRYKER. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." LEFT HIP.
Patient problems: Insufficient Information
MAUDE report 20746226 ↗InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "DATE OF AWARENESS IS YESTERDAY. PATIENT REVISED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. LEFT HIP." A COMPETITOR PROXIMAL BODY, FEMORAL HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 20453456 ↗InjurySep 16, 2024Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible
PATIENT RECEIVED LTHA. WASN¿T HAPPY WITH IT SO CUP SCREW WAS REMOVED AND CUP WAS REVISED. MDM WAS IMPLANTED. PATIENT WAS OUT OF STATE AND DISLOCATED. PATIENT WAS CLOSED REDUCED. WHEN THE PATIENT GOT HOME THEY NOTICED A SOUND COMING FROM THE HIP. DIDN¿T FEEL RIGHT. CAME INTO THE DOCTORS CLINIC AND THE DOCTOR NOTICED ON X RAY THE MDM LOOKED TO BE DISASSOCIATED. WE JUST REVISED THE MDM AND INDEED IT WAS DISASSOCIATED. UPDATE: SALES REP CONFIRMED THE METAL HEAD DISASSOCIATED FROM THE ADM LINER. UPDATE 09/SEPTEMBER/2024: SPOKE TO REP. REP CONFIRMED SURGICAL PROTOCOL WAS FOLLOWED EXACTLY. NOTHING UNUSUAL FOR ASSEMBLY OR IMPLANTATION. THE HEAD IS CHECKED EACH TIME TO ENSURE THAT IT IS PROPERLY SEATED.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 20230877 ↗InjurySep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT RECEIVED PRIMARY THA. THE THA WAS REVISED IN THE FUTURE (REASON UNKNOWN) RESTORATION MODULAR AND MDM. PATIENT THEN HAD A DIS ASSOCIATION OF MDM AFTER THE FIRST REVISION. PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2024 FOR MDM REVISION. UPDATE 09/SEPTEMBER/2024 WG: SPOKE TO REP. REP CONFIRMED SURGICAL PROTOCOL WAS FOLLOWED EXACTLY. NOTHING UNUSUAL FOR ASSEMBLY OR IMPLANTATION. THE HEAD IS CHECKED EACH TIME TO ENSURE THAT IT IS PROPERLY SEATED.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 20183922 ↗InjuryJun 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT HIP REVISION DUE TO DISASSOCIATION BETWEEN THE ADM LINER AND COMPETITOR 28MM HEAD. IT WAS DECIDED TO EXCHANGE THE BEARING SURFACE TO A CONSTRAINED INSERT. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.
Patient problems: Joint Dislocation
MAUDE report 19640547 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 18 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18911083 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 25 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910965 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 14 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910962 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 21 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910901 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 5 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910900 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 9 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910899 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 20 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910897 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 13 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910896 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 10 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910895 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 12 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910892 ↗InjuryMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY. NOTIFIED BY TGA. NO FURTHER DETAILS AVAILABLE. THIS PI CAPTURES THE 23 OF 25 EVENTS.
Patient problems: Insufficient Information
MAUDE report 18910891 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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