AccoladeRecalls & reported problems across all models
Howmedica Osteonics Corp. · 57 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,228
- Deaths reported
- 1
- Injuries reported
- 1,202
- Recalls
- 0
We found 57 models of Accolade by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 1,228 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2014 and Sep 25, 2026 — classified as 1 death, 1,202 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (347 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Accolade problems
Device problems
- Insufficient Device Problem Information347
- Degraded277
- Adverse Event Without Identified Device or Use Problem223
- Detachment of Device or Device Component181
- Material Erosion155
- Device Dislodged or Dislocated112
- Corroded88
- Fracture85
Patient problems
- Injury554
- Pain265
- Bone Fracture(s)224
- Metal Related Pathology207
- Ambulation or Postural Difficulties199
- Reaction175
- Inflammation168
- Insufficient Information146
Accolade models
57 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accolade 6021-0335Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented93 reports
- Accolade 6021-0435Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- Accolade 6721-0535Prosthesis, hip, semi-constrained, metal/polymer, cemented84 reports
- Accolade 6721-0435Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate82 reports
- Accolade 6021-4535Prosthesis, hip, semi-constrained, metal/polymer, cemented70 reports
- Accolade 6021-3535PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED68 reports
- Accolade 6721-0330Prosthesis, hip, hemi-, femoral, metal1 death55 reports
- Accolade 6721-0635Prosthesis, hip, constrained, cemented or uncemented, metal/polymer50 reports
- Accolade 6021-0537Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- Accolade 6720-0535Prosthesis, hip, hemi-, femoral, metal39 reports
- Accolade 6720-0435PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED38 reports
- Accolade 6721-0737Prosthesis, hip, semi-constrained, metal/polymer, cemented38 reports
- Accolade 6021-2530Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented37 reports
- Accolade 6720-0635Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented36 reports
- Accolade 6020-0335Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- Accolade 6021-0230PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED34 reports
- Accolade 6020-0230Prosthesis, hip, semi-constrained, metal/polymer, uncemented26 reports
- Accolade 6020-0435Prosthesis, hip, constrained, cemented or uncemented, metal/polymer26 reports
- Accolade 6020-4535Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented24 reports
- Accolade 6020-0537Prosthesis, hip, semi-constrained, metal/polymer, cemented23 reports
- Accolade 6020-3535Prosthesis, hip, semi-constrained, metal/polymer, uncemented21 reports
- Accolade 6720-0737Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate19 reports
- Accolade 6020-2530Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate18 reports
- Accolade 6720-0330Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 reports
- Accolade 6021-5537Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous17 reports
- Accolade 6721-0230Prosthesis, hip, semi-constrained, metal/polymer, uncemented15 reports
- Accolade 6721-0837Prosthesis, hip, semi-constrained, metal/polymer, uncemented15 reports
- Accolade 6720-0837Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous14 reports
- Accolade 6021-0637Prosthesis, hip, semi-constrained, metal/polymer, uncemented13 reports
- Accolade 6021-0130Prosthesis, hip, semi-constrained, metal/polymer, cemented11 reports
- Accolade 6020-0637Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7 reports
- Accolade 6721-0937Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- Accolade 6020-0130Prosthesis, hip, hemi-, femoral, metal6 reports
- Accolade 6020-5537PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED5 reports
- Accolade 6720-0230Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- Accolade 6721-0127Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Accolade 6058-0435DProsthesis, hip, constrained, cemented or uncemented, metal/polymer5 reports
- Accolade 6077-0335PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED4 reports
- Accolade 6077-0537Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous4 reports
- Accolade 6021-0030Prosthesis, hip, hemi-, femoral, metal3 reports
- Accolade 6021-0740PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Accolade 6721-1040PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Accolade 6720-0127Prosthesis, hip, hemi-, femoral, metal2 reports
- Accolade 6720-0937Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous2 reports
- Accolade 6057-0537DProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish2 reports
- Accolade 6020-0030Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Accolade 6020-0740Prosthesis, hip, hemi-, femoral, metal1 report
- Accolade 6020-0840Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Accolade 6720-1040Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Accolade 6721-1140Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Accolade 6057-0230DProsthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Accolade 6058-0335DPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Accolade 6058-0537DProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate1 report
- Accolade 6058-0637DProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Accolade 6077-0230Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous1 report
- Accolade 6077-0435PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Accolade 6077-0637Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
Recent Accolade adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Patient Device Interaction Problem
The following information was provided: Incoming letter from the user: Can you provide a document containing the necessary information about the composition (in terms of metals) of the endoprosthesis? I am currently dealing with a systemic immune reaction to the prosthesis (which was implanted in (b)(6)). I am scheduled for a revision (replacement), so it is absolutely essential to determine which metal I am allergic to in order to select a prosthesis made of alloys that are suitable specifically for me. I would very much like to minimize the risk of becoming disabled.
Patient problems: Foreign Body Reaction
MAUDE report 50896026 ↗InjurySep 16, 2026Detachment of Device or Device Component
Patient problems: Joint Dislocation
MAUDE report 50794455 ↗InjurySep 2, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50573015 ↗InjurySep 2, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50572826 ↗InjuryAug 31, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 50518139 ↗InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HAD A RIGHT PRIMARY THA ON (B)(6) 2025.PATIENT HAD A FEMUR PERI-PROSTHETIC FRACTURE TYPE B2. PATIENT WAS REVISED ON (B)(6) 2025.ONLY FEMORAL COMPONENT AND HEAD WERE REVISED.
Patient problems: Periprosthetic fracture
MAUDE report 25766626 ↗InjuryMay 28, 2026Material Erosion
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2015 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2025 DUE TO ALLEGED PSEUDOTUMOR AND TRUNNIONOSIS.
Patient problems: Insufficient Information
MAUDE report 25315845 ↗InjuryMay 28, 2026Material Erosion
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2025 DUE TO ALLEGED PAIN AND SIGNS OF METALLOSIS.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 25315525 ↗InjuryMay 28, 2026Material Erosion
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED BY PATIENT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2014 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM WHICH WAS REVISED ON (B)(6) 2024 DUE TO INCREASING PAIN, ELEVATED COBALT AND CHROMIUM LEVELS AND ALTR.
Patient problems: Foreign Body Reaction; Pain
MAUDE report 25315223 ↗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) 2012 AND WAS IMPLANTED WITH LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM THAT WAS SUBSEQUENTLY REVISED ON (B)(6) 2023 DUE TO ALLEGED HEAD DISASSOCIATION.
Patient problems: Insufficient Information
MAUDE report 25306922 ↗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 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO AN EXTENDED FEMUR FRACTURE (FRACTURE EXTENDED DOWN THE FEMUR). THE ENTIRE HEMI HIP CONSTRUCT WAS REMOVED AND A NEW HEMI HIP WITH A RESTORATION MODULAR STEM CONSTRUCT WAS IMPLANTED. REP WILL TRY TO OBTAIN ORIGINAL IMPLANT INFORMATION AND RETURN THE EXPLANTS, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s)
MAUDE report 25200861 ↗InjuryMay 6, 2026Material Erosion; Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: THE HIP GIVES WAY, RESULTING IN A FALL DURING AN EVERYDAY ACTIVITY; AN X-RAY SUBSEQUENTLY REVEALS A CONICAL FRACTURE OF THE FEMORAL SHAFT.
Patient problems: Bone Fracture(s); Fall; Periprosthetic fracture
MAUDE report 25091282 ↗InjuryMay 1, 2026Degraded; Fracture
No new information.
Patient problems: Metal Related Pathology; Osteolysis; Pain
MAUDE report 25054625 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS CASE: PERIPROSTHETIC LEFT ACETABULAR FRACTURE WITH ACETABULAR LOOSENING. HE ALSO HAS METALLOSIS AND LIKELY BONY NECROSIS MAKING A STANDARD HEMISPHERICAL COMPONENT LIKELY TO FAIL. SPOKE TO REP, REP WILL TRY TO GET ADDITIONAL PRODUCT INFORMATION WHEN THE REVISION IS PERFORMED (EXPECTED IN (B)(6) 2026). OTHERWISE, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. ADDITIONAL INFORMATION RECEIVED 25-MAR-26, "THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION HIP SURGERY [ON (B)(6) 2026] FROM A PRIMARY HIP TO AN FDA AND IRB APPROVED STRYKER COMPASSIONATE USE PSS DEVICE. THE PATIENT'S PELVIS WAS REPORTED AS FRACTURED, AND IT REQUIRED THIS DEVICE ALONG WITH MULTIPLE SCREWS AND A RESTORATION MODULAR FEMORAL HIP STEM TO RESTORE STABILITY TO THE JOINT."
Patient problems: Inadequate Osseointegration; Metal Related Pathology; Necrosis; Periprosthetic fracture
MAUDE report 24941365 ↗
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
- EXETER36 models · 344 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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