Restoration 6276-3-004Recalls & reported problems
Howmedica Osteonics Corp. · Modular Hip System · 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 04546540641540), received between Oct 4, 2018 and Oct 4, 2018 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Injury2
- Reaction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2015. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HER BLOOD.
Patient problems: Injury; Reaction
MAUDE report 7935396 ↗InjuryOct 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LIFT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2014 AND WAS REVISED ON (B)(6) 2015. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL, EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HER BLOOD.
Patient problems: Injury; Reaction
MAUDE report 7935297 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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