Restoration 1235-2-522Recalls & reported problems
Howmedica Osteonics Corp. · ADM- Cup w/HA · Class 2 · Implant
All models of Restoration (86)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540638755), received between Oct 13, 2020 and Oct 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (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 18, 2026.
Most reported problems
Device problems
- Degraded1
Patient problems
- Local Reaction1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2020Degraded; Degraded
IT IS REPORTED THAT: PATIENT IS ASYMPTOMATIC. INFORMATION RECEIVED FROM LEGAL ON (B)(6) 2015: PLAINTIFF ALLEGES THE LEFT REJUVENATE HIP IMPLANTED ON (B)(6)10 FAILED CAUSING PAIN AND ELEVATED METAL ION LEVELS. PLAINTIFF HAS NOT YET SCHEDULED REVISION SURGERY. SUIT FILED IN MINNESOTA. UPDATE (B)(6) 2020 WG: SPOKE TO REP VIA PHONE. IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2020 DUE TO ALTR. ALL COMPONENTS WERE REVISED. REP PROVIDED THE PRIMARY USAGE REPORT AND CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER. THE SHELL WAS REVISED BOTH TO CHANGE ITS POSITION AND ALLOW FOR AN MDM METAL LINER AND ADM/ MDM POLY INSERT TO BE IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Local Reaction; Pain
MAUDE report 10669679 ↗
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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page