Accolade 6721-0127Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540669469), received between Jul 27, 2022 and Jun 4, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Corroded” (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 Problem3
- Corroded1
- Migration1
- Unintended Movement1
Patient problems
- Bone Fracture(s)2
- Discomfort1
- Foreign Body Reaction1
- Insufficient Information1
- Metal Related Pathology1
- Pain1
- Unequal Limb Length1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERIPROSTHETIC FEMORAL STEM FRACTURE OCCURRED AFTER INITIAL SURGERY. REVISION SURGERY IS PLANED ON 19 MAY.
Patient problems: Bone Fracture(s)
MAUDE report 22139526 ↗InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A LEFT HIP REVISION DUE TO POST OPERATIVE DISCOMFORT. INVESTIGATIVE REVISION PERFORMED TO DETERMINE INFECTION, NO ACTIVE INFECTION DURING THIS PROCESS, DETERMINED REASON FOR REVISION WAS METALLOSIS.
Patient problems: Discomfort; Foreign Body Reaction
MAUDE report 17649298 ↗InjuryOct 18, 2022Corroded; Corroded
IT WAS REPORTED THAT FOLLOWING DETECTION OF A HIGH LEVEL OF IONS METAL IN PATIENT BLOOD WITH LUMP IT WAS DISCOVERED THERE WAS TRUNNIONOSIS ON THE ACCOLADE 2 WITH 32MM METAL HEAD. REVISION CASE: REMOVED FEMORAL HEAD, IMPLANTED TITANIUM SLEEVE +4MM WITH UNIVERSAL BIOLOX 32MM HEAD. BLACK CORROSION WAS VISIBLE ON ACCOLADE 2 TRUNNION AND INSIDE THE 32MM METAL HEAD.
Patient problems: Metal Related Pathology
MAUDE report 15623961 ↗InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS (NOTHING LOOSE, WORN, BROKEN, ETC). THE STEM, HEAD, AND LINER WERE REVISED TO ANOTHER LINER AND COMPETITOR FEMORAL COMPONENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain
MAUDE report 15604773 ↗InjuryJul 27, 2022Unintended Movement; Migration; Unintended Movement; Migration
5 WEEK FOLLOW UP SHOWS ACCOLADE2 STEM SUBSIDENCE. PATIENT PRESENTED WITH MAL ALIGNED AND SHORT LEG. CT SHOWS FEMORAL FRACTURE. SURGEON REPORTS NO INTRAOP FRACTURE NOTED. PATIENT DENIES FALL.
Patient problems: Bone Fracture(s); Insufficient Information; Unequal Limb Length
MAUDE report 15109702 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 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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