Accolade 6020-2530Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540510617), received between Jul 25, 2017 and Jan 6, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (8 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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HER RIGHT HIP WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO ELEVATED METAL IONS AND MRI FINDINGS CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 21081842 ↗
• InjuryOct 23, 2023Degraded; Material Erosion; Degraded; Material Erosion

  OBSERVED TRUNNIONOSIS DURING TOTAL HIP REVISION. STEM WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 17983642 ↗
• InjuryJun 27, 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 DUE TO TRUNNION WEAR AND HEAD DISSOCIATION. INTRA-OPERATIVELY, BLACK TISSUE WAS NOTED IN THE PATIENT, AND IT WAS OBSERVED THAT THE TRUNNION HAD DUG INTO (BUT NOT PERFORATED) THE LINER. REP WILL PROVIDE ANY PICTURES AND DOCUMENTS AVAILABLE TO HIM FROM THE HOSPITAL AND SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Metal Related Pathology

  MAUDE report 17209122 ↗
• InjuryMay 3, 2023Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION WEAR. THE HEAD AND LINER WERE REVISED TO A METAL HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16859148 ↗
• InjuryMar 16, 2022Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem; Corroded; Material Erosion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2017 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 13790625 ↗
• InjuryFeb 21, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 13573621 ↗
• InjuryMay 6, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED TRUNNIONOSIS AND PSEUDOTUMOR.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11783090 ↗
• InjuryDec 5, 2019Corroded; Degraded; Insufficient Device Problem Information; Corroded; Degraded; Insufficient Device Problem Information

  DR. PERFORMING REVISION MENTIONED BLACK RESIDUE ON STEM AND INSIDE OF FEMORAL HEAD AND IMPLANTS WERE EXTRACTED FROM PATIENT. OSTEOREMEDIIES ANTIBIOTIC SPACERS USED.

  Patient problems: Injury

  MAUDE report 9417927 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, PATIENT'S HIP : "REVISED FOR PAIN. DOCTOR...WAS ABLE TO REMOVE HER ACCOLADE STEM AND PUT IN A RESTORATION MODULAR IMPLANT." REP PROVIDED USAGE INFORMATION FROM THE (B)(6) 2010 IMPLANTATION.

  Patient problems: Injury; Pain

  MAUDE report 9383580 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER LEFT HIP ON OR ABOUT (B)(6), 2008 AND WAS REVISED ON (B)(6), 2015. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 8887639 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A DISLOCATED LEFT HIP. XRAY INDICATED A DISSOCIATION OF THE STEM AND HEAD AS WELL AS A DAMAGED TRUNNION. A REVISION WAS PERFORMED AND ALL IMPLANTS WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 8603751 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CONSUMER UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2014 . ITS FURTHER ALLEGED THAT THE HIP FAILED DUE TO ALLEGED ALTR. NOT REVISED YET.

  Patient problems: Injury

  MAUDE report 8273696 ↗
• InjuryJan 8, 2019Corroded; Corroded

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND AFTER IMPLANTATION DEVELOPED PAIN IN HER REPLACED HIP AND METAL ION TESTING DEMONSTRATED ELEVATED COBALT AND CHROMIUM LEVELS. THE PATIENT WAS REVISED ON (B)(6) 2017 AND DURING THE REVISION SURGERY "A VERY SIGNIFICANT AMOUNT OF CORROSION WAS EVIDENT AT THE BASE OF THE TRUNNION".

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8226165 ↗
• InjuryNov 28, 2018Degraded; Degraded

  ITS REPORTED BY THE HUSBAND, THAT HIS WIFE UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. IT IS FURTHER ALLEGED THAT THE HIP FAILED AND SHE IS SCHEDULED FOR REVISION ON (B)(6) 2018. UPDATE (B)(6) 2018 - AS REPORTED BY REP VIA FAX, PATIENT WAS REVISED (B)(6) 2018: "PATIENT WAS BROUGHT IN FOR REVISION SURGERY ON RIGHT HIP. [SURGEON] DEBRIDED COPIOUS AMOUNTS OF SOFT TISSUE, DAMAGED FROM WHAT HE DESCRIBED AS METAL DEBRIS. [SURGEON] REMOVED THE LINER AND HEAD AND NOTED BLACK METAL DEBRIS PRESENT ON...TRUNNION AND INSIDE HEAD. PATIENT HAD A LOT OF DISCOLORED FLUID AND TISSUE REMOVED...[SURGEON] DEEMED THE ABDUCTORS INSUFFICIENT FROM THE DAMAGE AND WAS FORCED TO IMPLANT A CONSTRAINED LINER FOR STABILITY..."

  Patient problems: Fluid Discharge; Inflammation; Injury; Reaction; Tissue Damage

  MAUDE report 8112857 ↗
• InjuryOct 18, 2018Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2014. 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 COBALT AND CHROMIUM IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Reaction

  MAUDE report 7980259 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AND FRACTURED LEFT HIP. SENT TO ER AND REVISION HIP REPLACEMENT WAS DONE. AS REPORTED IN "HOW WAS ISSUE NOTICED": AFTER PATIENT FELL. DATE OF PRIMARY SURGERY WAS DONE 2009. UPDATE 20-JUL-2018: SPOKE TO REP. PERIPROSTHETIC BONE FRACTURE, PROXIMAL FEMUR EXTENDING DISTALLY. NO DEVICE FAILURES WERE REPORTED AS CAUSE OR CONTRIBUTION TO PATIENT'S FALL.

  Patient problems: Fall; Injury

  MAUDE report 7780418 ↗
• InjuryJul 10, 2018Degraded; Degraded

  REVISION OF LUXATED HIP REVEALED MASSIVE LOSS OF SOFT TISSUE AROUND GREATER TROCHANTER AND ACCOMPANYING PARTICLE DEBRIS AROUND THE SPIGOT, INSIDE THE HEAD TRUNNION AND IN THE WOUND AS A BLACK PATTERN. THE PRODUCTS REVISED WERE ACCOLADE TMZF WITH TRIDENT CUP. THE STEM, HEAD AND LINER WERE RETRIEVED AND AVAILABLE FOR FURTHER INSPECTION. AS TO MARKS ON THE STEM, THE SURGEON USED ONLY OSTEOTOMIES AROUND THE PROXIMAL PART OF THE FIXATION ZONE AND NOT ON THE TRUNNION. MARK ON THE HEAD ONLY ON THE OUTSIDE TO TAP OUT THE HEAD. THE STEM WAS WITHDRAWN WITH THE THREADED ACCOLADE2 INSERTER. NO OTHER MARKS WERE CAUSED BY USING OSTEOTOMY OR OTHER INSTRUMENT.

  Patient problems: Injury; Joint Dislocation; Tissue Damage

  MAUDE report 7674935 ↗
• MalfunctionJul 25, 2017Packaging Problem; Packaging Problem

  DURING PRIMARY HIP REPLACEMENT SURGERY THE SURGEON ASKED FOR AN ACCOLADE TMZF 2.5 132 STEM, FROM AN UNDAMAGED UNOPENED BOX THE IMPLANT BOX WAS OPENED PER NORMAL, AT THAT TIME THE NURSE NOTICED THE OUTER LID WAS NOT SEALED AND OPENED, FURTHER INSPECTION WAS GIVEN AND THE INNER LID WAS OPENED AS WELL MAKING THE IMPLANT CONTAMINATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6740735 ↗