Restoration 6276-7-216Recalls & 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
- 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 07613154058778), received between May 31, 2019 and Jan 6, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
Patient problems
- Ambulation or Postural Difficulties1
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2023Fracture; Fracture
RESTORATION MODULAR STEM BROKEN WHILE IN THE PATIENT. THE STEM AND PROXIMAL CONE AND FEMORAL HEAD HAS BEEN REMOVED - THE DISTAL PART REMAINS IN THE PATIENT. AN 205 CEMENTED EXETER STEM HAS BEEN USED.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16118692 ↗InjuryMay 31, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE DISTAL PORTION OF THE DISTAL STEM BREAKING INSIDE THE PATIENT'S FEMUR. NO POSSIBLE CAUSE OR CONTRIBUTOR WAS REPORTED TO THE REP. PATIENT'S RESTORATION MODULAR STEM AND A FEMORAL HEAD WERE REVISED TO COMPETITOR DEVICES. REP PROVIDED PRE-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Injury
MAUDE report 8658102 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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