Accolade 6077-0537Recalls & reported problems
Howmedica Osteonics Corp. · 127 Degree Neck Angle Hip Stem · Class 2 · Implant
All models of Accolade (57)
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 07613327021219), received between Dec 3, 2019 and Apr 30, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Fall1
- Injury1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "REV RTHA - PERIPROSTHETIC FRACTURE. ACCOLADE HFX AND 36MM +10 HEAD COMING OUT AND COMPETITOR GOING BACK IN. ORIGINAL CUP IS ALSO COMPETITOR. " SPOKE WITH REP. REP CONFIRMED FEMORAL FRACTURE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s)
MAUDE report 19215320 ↗InjuryJan 12, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
PATIENT HIP DISLOCATION WITH DISSOCIATION OF FEMORAL HEAD FROM STEM. RIGHT HIP.
Patient problems: Ambulation or Postural Difficulties; Joint Dislocation
MAUDE report 16154038 ↗InjuryJan 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT REPORTED SHE HAS BEEN EXPERIENCING PAIN SINCE HER RIGHT PARTIAL HIP SURGERY AND WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF RECALL.
Patient problems: Pain
MAUDE report 9624308 ↗InjuryDec 3, 2019Fracture; Fracture
AS REPORTED: "PATIENT'S LEFT HIP WAS REVISED DUE TO FEMUR FRACTURE SUSTAINED AFTER A FALL. FEMUR WAS REVISED TO A RESTORATION MODULAR STEM AND AN ENDO HEAD. ALL INFORMATION THAT IS AVAILABLE ON THIS PATIENT IS INCLUDED IN THIS REPORT." SPOKE TO REP, WHO CONFIRMED THAT FRACTURE WAS OF THE PATIENT'S NATIVE FEMUR AND NOT ANY IMPLANTS. THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD OR BIPOLAR COMPONENT. REP PROVIDED THE PRIMARY USAGE SHEET AND RE-CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Fall; Injury
MAUDE report 9400700 ↗
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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