Accolade 6021-0435Recalls & reported problems
Howmedica Osteonics Corp. · 127 Degree Neck Angle Hip Stem · Class 2 · Implant
Quick summary
This Accolade hip stem from Howmedica Osteonics is an implant used in hip replacement surgery. Many of its 88 reports describe the head separating from the stem and worn or corroded parts, often requiring revision surgery. All 88 are injury reports, with no deaths. Reports rose from 3 in the prior 12 months to 6 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 04546540510693), received between Jul 30, 2014 and May 27, 2026 — classified as 88 injuries.
The most frequently reported specific device problem is “Degraded” (28 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded28
- Detachment of Device or Device Component28
- Insufficient Device Problem Information16
- Material Erosion16
- Corroded11
- Adverse Event Without Identified Device or Use Problem10
- Device Dislodged or Dislocated10
- Fracture6
Patient problems
- Injury39
- Ambulation or Postural Difficulties26
- Insufficient Information19
- Pain19
- Reaction18
- Inflammation17
- Metal Related Pathology15
- Foreign Body Reaction8
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2011 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 25304276 ↗InjuryApr 14, 2026Degraded; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: "COMPONENT FAILURE, SEVERE WEAR OF THE TAPER ON THE ACCOLADE TMFZ FEMORAL COMPONENT (THA) AFTER 8 YEARS. FAILED FEMORAL HEAD AND SEVERE METALLOSIS."
Patient problems: Insufficient Information; Metal Related Pathology
MAUDE report 24874279 ↗InjuryMar 17, 2026Degraded; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: THE STEM WAS NOTCHED, THE TRUNNION WAS WORN, AND BLACK TISSUE WAS OBSERVED. THE STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CAN PROVIDE PICTURES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology
MAUDE report 24616799 ↗InjuryMar 3, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2018 WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF STEM WHICH WAS REVISED ON (B)(6) 2024 DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 24494637 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO STEM LOOSENING. THE STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, HEAD AND LINER. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED HEAD AND LINER.
Patient problems: Inadequate Osseointegration
MAUDE report 23826295 ↗InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A LEFT THA ON (B)(6) 2008, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD. HE SUBSEQUENTLY WAS REVISED ON (B)(6) 2025, AND INTRAOPERATIVELY IT WAS NOTED THAT THE STEM TRUNNION HAD A PENCIL TIP DEFORMITY, AND THE HEAD BALL HAD FALLEN OFF COMPLETELY.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 23610405 ↗InjuryAug 21, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component
InjuryDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2010 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. THE RIGHT HIP WAS REVISED ON (B)(6) 2023 ALLEGEDLY DUE TO HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 20896324 ↗InjuryNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH A LFIT ANATOMIC V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. SHE WAS REVISED ON (B)(6) 2021, DUE TO ALLEGED FEMORAL HEAD DISSOCIATION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 20693406 ↗InjuryOct 18, 2024Material Erosion; Material Erosion
DR SCHEDULED A REVISION THA SECONDARY TO A PATIENT HAVING MULTIPLE DISLOCATIONS. THE INDEX PROCEDURE WAS BELIEVED TO HAVE BEEN DONE AROUND 2006. EXPOSURE OF THE JOINT REVEALED SIGNIFICANT METALLOSIS AND TRUNNION DAMAGE. DR DECIDED TO REPLACE THE POLYETHYLENE LINER, REMOVE THE STEM AND IMPLANTED A COMPETITOR HIP STEM.
Patient problems: Joint Dislocation
MAUDE report 20479059 ↗InjuryJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED HEAD DISSOCIATION.
Patient problems: Insufficient Information
MAUDE report 19643511 ↗InjuryJul 1, 2024Corroded; Corroded
IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP REVISION DUE TO TRUNNION CORROSION.
Patient problems: Insufficient Information
MAUDE report 19643238 ↗InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REVISED A V-40 L-FIT HEAD 36 +5, REPLACED BY A BIOLOX C-TPR HEAD WITH A SLEEVE. PER MEDICAL RECORDS RECEIVED: THE PATIENT WAS REVISED DUE TO ELEVATED METAL ION LEVELS AND WAS OTHERWISE ASYMPTOMATIC. THE FEMORAL HEAD AND LINER WERE REVISED.
Patient problems: Metal Related Pathology
MAUDE report 19249168 ↗InjuryApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 19112453 ↗InjuryMar 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON SEPTEMBER 6, 2013 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 18940489 ↗InjuryNov 2, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "THE REVISION WAS SECONDARY TO PAIN FROM DISLOCATION. THE DISLOCATION WAS IDENTIFIED RADIOGRAPHICALLY TO HAVE OCCURRED BETWEEN THE FEMORAL STEM AND FEMORAL HEAD. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."
Patient problems: Ambulation or Postural Difficulties
MAUDE report 18062218 ↗InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS PI IS FOR THE INTRA-OP FRACTURE IN 2009. WHILE COVERING A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2023, REP WAS TOLD THAT PATIENT HAD AN INTRA-OPERATIVE FRACTURE OF THE TROCHANTER DURING THE PRIMARY PROCEDURE. A CABLE WAS USED TO ADDRESS THE FRACTURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s)
MAUDE report 17983376 ↗InjuryOct 20, 2023Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SIGNIFICANT TRUNNION DAMAGE AND PARTIAL DISSOCIATION OF THE FEMORAL HEAD. THE STEM AND HEAD WERE REVISED.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 17974566 ↗InjuryJul 12, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
ON (B)(6) 2008 IMPLANTATION OF A STRYKER HIP PROSTHESIS WITH TRIDENT SCREW ACETABULAR CUP, PE INLAY, ACCOLADE STEM, METAL HEAD. IN THE COURSE NOW INCREASING INSTABILITY WITH MULTIPLE FALLS. ON 5/17/2023 EVIDENCE OF PREMATURE MATERIAL WEAR. V.A IMPLANT FRACTURE, REVISION SURGERY ON (B)(6) 2023 WITH MASSIVE METALLOSIS AND EVIDENCE OF COMPLETE WEAR OF THE METAL FEMORAL NECK.
Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions
MAUDE report 17307041 ↗InjuryJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY ON (B)(6) 2010, THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. IT IS FURTHER ALLEGED THE PATIENT WAS REVISED ON (B)(6) 2022, DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM THE TRUNNION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 17056903 ↗InjuryApr 3, 2023Degraded; Fracture; Degraded; Fracture
THE NECK OF THE STEM WAS BROKEN. LIMITED ACTIVITIES.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology
MAUDE report 16668790 ↗InjuryApr 2, 2023Corroded; Corroded
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY ON (B)(6) 2008. SHE UNDERWENT REVISION ON (B)(6) 2022 WITH A PREOPERATIVE DIAGNOSIS OF CORROSION RIGHT HIP. AFTER REMOVING THE LARGE METAL HEAD, "THERE WAS EVIDENCE OF SOME CORROSION AT THE BASE OF THE TAPER."
Patient problems: Insufficient Information
MAUDE report 16661046 ↗InjuryMar 30, 2023Corroded; Corroded
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2021 AND INTRAOPERATIVELY THE SURGEON NOTED "THE TAPER WAS COMPLETELY CORRODED AD WHITTLED DOWN TO A PENCIL TYPE SHAPE."
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16644365 ↗InjuryFeb 22, 2023Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component
IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. ORIGINALLY, SURGEON SUSPECTED THE STEM HAD SUBSIDED 8-10MM. HOWEVER, INTRA-OPERATIVELY THE STEM WAS NOT FOUND TO BE LOOSE. BLACK DEBRIS WAS FOUND IN THE HIP CAPSULE AND DOWN THE FEMUR. A DEBRIDEMENT WAS PERFORMED. THE FEMORAL HEAD WAS ABLE TO BE REMOVED BY HAND AND THE TRUNNION OF THE STEM OBSERVED TO BE WORN DOWN TO A PENCIL SHAPE. THE STEM, HEAD AND LINER WERE REVISED (NO DAMAGE OR WEAR OF THE LINER WAS NOTED).
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 16416148 ↗InjuryFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE PATIENT 'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND WAS IMPLANTED WITH A 36 MM +0 LFIT ANATOMIC V40 FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO HEAD DISASSOCIATION.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 16292156 ↗
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
- 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
- Avenir® 01.06010.001Zimmer GmbH · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.