Restoration 6276-7-116Recalls & reported problems
Howmedica Osteonics Corp. · Modular Hip System · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154058624), received between Feb 2, 2017 and Nov 2, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Degraded1
- Fracture1
- Naturally Worn1
- Unintended Movement1
Patient problems
- Pain2
- Bone Fracture(s)1
- Foreign Body Reaction1
- Inadequate Osseointegration1
- Metal Related Pathology1
- Perforation1
- Reaction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2023Degraded; Degraded
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT HIP SURGERY ON (B)(6) 2010, AND WAS IMPLANTED WITH A RESTORATION MODULAR HIP SYSTEM AND A LFIT V40 COCR FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2022, DUE TO PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND ALTR.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 18054157 ↗InjuryNov 15, 2021Fracture; Unintended Movement; Insufficient Device Problem Information; Fracture; Unintended Movement; Insufficient Device Problem Information
PATIENT HAD RIGHT INDEX THA (OUTSIDE OF CORS SCOPE). PATIENT FELT AND HAD A FEMUR PPFX (B2) UNDERWENT REVISION ON (B)(6) 2019. ONLY FEMUR AND HEAD EXCHANGED. PATIENT RETURNS WITH PAIN AND AN ADDITIONAL FEMORAL (B2) PPFX AND SUBSIDENCE OF FEMORAL COMPONENT. UNDERGOES REVISION ON (B)(6) 2021. FEMUR, HEAD, AND LINER ARE EXCHANGED.
Patient problems: Bone Fracture(s)
MAUDE report 12813297 ↗InjuryFeb 2, 2017Naturally Worn; Insufficient Device Problem Information; Insufficient Device Problem Information
THE SALES REP CONFIRMED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION OF A DUPUY HIP SYSTEM DUE TO METAL-ON-METAL WEAR. THE RESTORATION MODULAR STEM THAT WAS IMPLANTED WAS TOO LONG AND PERFORATED THE PATIENT¿S FEMUR. ON (B)(6) 2017, THE SURGEON REMOVED THE RESTORATION MODULAR STEM, CUT IT AND RE-IMPLANTED IT BACK INTO THE PATIENT. PATIENT IN LESS PAIN THAN THE FIRST OPERATION. THE ONLY DEVICE REPLACED DURING THIS PROCEDURE WAS THE CERAMIC HEAD.
Patient problems: Inadequate Osseointegration; Pain; Perforation; Reaction
MAUDE report 6297332 ↗
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 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United 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 2515-3111United 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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