Restoration 6276-7-120Recalls & reported problems
Howmedica Osteonics Corp. · Modular Hip System · 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 07613154058662), received between Oct 17, 2019 and Oct 17, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THIS PI IS FOR THE GREATER TROCHANTERIC PERIPROSTHETIC FRACTURE OF THE PATIENT'S LEFT HIP. PROCEDURE: THE PATIENT HAD LEFT HIP REPLACEMENT HISTORY. PATIENT HAD TOTAL LEFT HIP ARTHROPLASTY SEVERAL YEARS AGO (OUTSIDE CORS SCOPE). PATIENT HAD PERSISTENT AND PROGRESSIVE PAIN IN THE LEFT HIP FOR MANY YEARS. X-RAYS CONFIRMED LOOSENING OF THE FEMORAL COMPONENT. REVISION OF BOTH ACETABULAR AND FEMORAL COMPONENTS 1/MARCH/2018. PATIENT HAD CHRONIC INFECTION AFTER REVISION ARTHROPLASTY, AND UNDERWENT LEFT HIP ARTHROPLASTY WITH PLACEMENT OF ANTIBIOTIC- LOADED CEMENT SPACER ON (B)(6) 2018. THE PATIENT PRESENTED DRAINAGE FROM LEFT THIGH INCISION AND IN (B)(6) 2019 HAD A RESECTION ARTHROPLASTY WITH ANTIBIOTIC-LOADED CEMENT SPACER FOR HIS INFECTED LEFT HIP. REVISION OF ALL COMPONENTS AND REMOVAL OF CEMENT SPACER (B)(6) 2019. PATIENT HAD LEFT HIP GREATER TROCHANTERIC FRACTURE (B1) AND SUBLUXATION SECONDARY TO FAILED FIXATION AFTER EXTENDED TROCHANTERIC OSTEOTOMY FOR HIP REVISION (B)(6) 2019. NO COMPONENTS EXCHANGED.
Patient problems: Bone Fracture(s); Injury
MAUDE report 9202715 ↗
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.
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