Restoration 6276-7-017Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540643759), received between Aug 16, 2018 and Mar 6, 2023 — classified as 4 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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information3
- Degraded1
Patient problems
- Injury3
- Bone Fracture(s)1
- Fall1
- Joint Dislocation1
- Metal Related Pathology1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2023Degraded; Degraded
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6), 2010 AND WAS REVISED ON (B)(6), 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.
Patient problems: Metal Related Pathology
MAUDE report 16492348 ↗InjuryMay 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT HAD SLIPPED AND FALLEN; FRACTURING AROUND THEIR HIP REPLACEMENT AND THUS DISLOCATING THEIR HIP. RESTORATION MODULAR STEM REVISED FOR A LONGER AND LARGER ONE; NO SURGICAL DELAY.
Patient problems: Bone Fracture(s); Fall; Injury; Joint Dislocation
MAUDE report 10039546 ↗InjuryFeb 7, 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. AS REPORTED BY REP: "CONVERSION FROM HEMI TO TOTAL HIP". A STRYKER HEMI HIP CONSTRUCT (UHR BIPOLAR COMPONENT, 26 -3 LFIT V40 HEAD, RESTORATION MODULAR STEM CONSTRUCT, DALL MILES CABLE AND SLEEVE SET) WERE THE PRIMARY IMPLANTS. PATIENT WAS REVISED TO ANOTHER RESTORATION MODULAR STEM CONSTRUCT, 28 +4 BIOLOX CERAMIC HEAD, MDM/ADM LINER CONSTRUCT, AND A 52E TRIDENT II SHELL WITH 2 SCREWS.
Patient problems: Injury
MAUDE report 8318067 ↗InjuryAug 16, 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. A RESTORATION MODULAR STEM CONSTRUCT WAS REVISED TO A LARGER CONSTRUCT, A CERAMIC HEAD WITH A SMALLER OFFSET, AND AN ADM POLY INSERT EXCHANGED FOR AN IDENTICAL IMPLANT.
Patient problems: Injury
MAUDE report 7790227 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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