Restoration 6276-1-121Recalls & 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
- 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 04546540641144), received between Jan 4, 2018 and Jan 14, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury3
- Osteolysis1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
AS REPORTED: "PAINFUL TOTAL LEFT HIP." THE PATIENT'S RESTORATION MODULAR STEM CONSTRUCT AND FEMORAL HEAD WERE REVISED TO COMPETITOR DEVICES. UPDATE AS PER MEDICAL REVIEW, 'ON (B)(6) 2019 A REVISION LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR A POST-OPERATIVE DIAGNOSIS OF ¿OSTEOLYSIS LEFT PROXIMAL FEMUR WITH PAIN.
Patient problems: Injury; Osteolysis; Pain
MAUDE report 9588674 ↗InjuryMar 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT HIP WAS REVISED. COMPARING CURRENT REVISION IMPLANT SHEET WITH THE PREVIOUS REVISION, A RESTORATION MODULAR 21 +10 CONE BODY AND 28 +8 LFIT METAL HEAD WERE REVISED TO THE SAME CATALOG NUMBER CONE BODY AND A 32 +4 BIOLOX HEAD.
Patient problems: Injury
MAUDE report 8424669 ↗InjuryJan 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED.
Patient problems: Injury
MAUDE report 7163865 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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