Restoration 1235-2-601Recalls & reported problems
Howmedica Osteonics Corp. · ADM- Cup w/HA · Class 2 · Implant
All models of Restoration (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540638823), received between Dec 14, 2020 and Mar 11, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Ambulation or Postural Difficulties1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
2019 REVISION EVENT DESCRIPTION: IN 2019, AN ADDITIONAL REVISION IS CITED THAT AN ¿ADM COBALT/ CHROMIUM CUP¿ WAS REMOVED AND REPLACED WITH TITANIUM [SHELL?] AND 3 SCREWS.
Patient problems: Insufficient Information
MAUDE report 13729225 ↗InjuryDec 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS PI IS FOR THE FIRST REVISION OF THE PATIENT'S RIGHT HIP. IN REPORTING A REVISION OF THE PATIENT'S HIP ON (B)(6) 2020, REP WAS TOLD THE PATIENT HAD A PRIOR REVISION APPROXIMATELY 8 YEARS AGO DUE TO THE ADM SHELL BEING IN A VERTICAL POSITION. THE ADM SHELL, ADM INSERT AND 28 +0 V40 HEAD WERE REVISED TO A TRITANIUM HEMISPHERICAL CLUSTER HOLE SHELL WITH 2 SCREWS, A 44G INSERT, AND 44 +4 LFIT HEAD. REP WAS NOT PRESENT FOR THE PROCEDURE.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 11001129 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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