Accolade 6020-4535Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04546540510631), received between Aug 20, 2018 and Jan 28, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Degraded” (9 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Material Erosion; Material Erosion

  RIGHT TOTAL HIP REVISION DUE TO EXCESSIVE FEMORAL STEM NECK TRUNNION WEAR. REVISED STEM, HEAD, ACETABULAR POLY LINER.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21251955 ↗
• InjuryAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT REVISED FOR FAILURE OF LEFT TOTAL HIP ARTHROPLASTY. GRAY TISSUE STAINING. DISSOCIATED HEAD AND STEM TRUNNION DAMAGE WERE NOTED. STEM AND HEAD WERE EXPLANTED AND REPLACED WITH NEW STEM (BELOW BILLING SHEET). CUP AND INSERT WERE RETAINED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 19994421 ↗
• InjuryJun 17, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE TRUNNION BEING 'COMPLETELY ERODED AWAY.'

  Patient problems: Insufficient Information

  MAUDE report 19547923 ↗
• InjuryMar 28, 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) 2012, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED DISSOCIATION OF THE FEMORAL HEAD FROM THE TRUNNION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 18992621 ↗
• InjuryMar 19, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REQUIRED REVISION SURGERY ON (B)(6) 2021 DUE TO ALLEGED LEFT HIP PAIN AND TRUNNIONOSIS.

  Patient problems: Pain

  MAUDE report 18935261 ↗
• InjuryApr 27, 2023Degraded; Degraded

  IN (B)(6) 2015, PATIENT UNDERWENT A TOTAL RIGHT HIP REPLACEMENT USING A STRYKER ACCOLADE TMZF 132* NECK ANGLE V40 HIP STEM AND A TRIDENT PSL HA SOLID BLACK ACETABULAR SHELL (56MM). ENCLOSED IS PATIENTS OPERATION REPORT CONFIRMING INSERTION OF THE STRYKER COMPONENTS ON (B)(6) 2015 AND IN (B)(6) 2021, PATIENT RETURNED TO HIS ORTHOPAEDIC SURGEON COMPLAINING OF SEVERE PAIN IN THE LEFT HIP AND GROIN. A FEW YEARS AFTER THE PROCEDURE, PATIENT BEGAN TO EXPERIENCE INCREASED PAIN IN THE RIGHT HIP AND RETURNED TO HIS SURGEON FOR ADVICE. PATIENT WAS INFORMED THAT THE HIP STEM HAD BROKEN DOWN AND FAILED. FURTHER SURGERY WAS REQUIRED TO INSERT A TEMPORARY RIGHT HIP FOLLOWED BY A PERMANENT RIGHT HIP REPLACEMENT SIX WEEKS LATER. AS A RESULT, PATIENT CONTINUES TO SUFFER FROM ONGOING PAIN AND DISABILITY IN THE RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16828209 ↗
• InjuryDec 15, 2022Degraded; Material Erosion; Degraded; Material Erosion

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 15985999 ↗
• InjuryDec 12, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: REVISION FOR TRUNNIONOSIS. NOTICED FROM HEAD DISSOCIATION. TRUNION MIS SHAPED, LINER WORE DOWN, BLACK RESIDUE. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15963886 ↗
• InjuryDec 12, 2022Material Erosion; Material Erosion

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN V40 COCR LFIT FEMORAL HEAD ON HIS LEFT HIP ON (B)(6) 2009. IT IS FURTHER ALLEGED THAT THE PATIENT EXPERIENCED PAIN. X-RAYS ALLEGEDLY SHOWED "BROKEN, WORN OUT TRUNNION AND THE ACETABULAR SOCKET APPEARED TO BE IN GOOD CONDITION." DURING REVISION SURGERY ON (B)(6) 2020, "THE WORN OUT TRUNNION WAS COMPLETELY CORRODED AND WEARING ON A SUPERIOR PORTION OF THE SOCKET. THE PLASTIC LINER WAS BROKEN IN THIS AREA AS WELL.".

  Patient problems: Pain

  MAUDE report 15957032 ↗
• InjuryOct 4, 2021Degraded; Degraded

  THE SURGEON IS ASKING HAS THERE BEEN ANY PRODUCT WARNINGS ON THE IMPLANTS AS HE SEES EVIDENCE OF METALLOSIS. UPDATE: THERE ARE SIGNS OF WEAR ON THE TRUNNION OF THE ACCOLADE TZMF STEM EVEN THOUGH IT WAS A COC ARTICULATION. NOTICED WHEN PATIENT REPORTED PAIN AND ON SCANS. REVISION COMPLETED ON (B)(6) 2021.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12568482 ↗
• InjuryApr 1, 2021Adverse 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 THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2016 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 11602330 ↗
• InjuryFeb 3, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. INTRA-OPERATIVELY, TRUNNION WEAR AND BLACK TISSUE IN THE PATIENT WERE NOTED. AN ACCOLADE TMZF STEM, 36 +0 LFIT HEAD, AND 36G 0° POLY INSERT WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, BIOLOX HEAD, AND A 36G 10° LINER. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO PROVIDED PRIMARY AND REVISION USAGE, INTRA-OP PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Inflammation; Insufficient Information

  MAUDE report 11276383 ↗
• InjurySep 17, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION TOTAL HIP REPLACE FOR ASEPTIC LOOSENING OF FEMORAL COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10547541 ↗
• InjuryJun 5, 2020Migration; Migration

  TEN YEARS AGO, THE PATIENT UNDERWENT THA PROCEDURE WITH ACCORLADE TMZF. ON (B)(6) 2020, SANK OF THE STEM WAS NOTED BY THE X-RAY. REVISION IS NOT SCHEDULED AT THE CURRENT SAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10124723 ↗
• InjuryFeb 14, 2020Adverse 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 BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON (B)(6) 2008. IT IS ALLEGED THAT THE PATIENT RECEIVED A LETTER FROM UPMC ON (B)(6) 2018 INFORMING HIM OF THE VOLUNTARY RECALL FOR POTENTIAL DEFECTS OF SAID IMPLANTS AND THAT HE SHOULD COME IN FOR TESTING. HE HAS BEEN REVISED ON UNKNOWN DATE.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9712518 ↗
• InjuryNov 6, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  SURGEON REVISED PRIOR THA FOR LOOSE FEMORAL HEAD. FEMORAL HEAD LOOSE ON TAPER.

  Patient problems: Injury

  MAUDE report 9285833 ↗
• InjuryOct 29, 2019Degraded; Degraded

  SALES REP REPORTED "DOCTOR SAYS THERE WAS EXCESSIVE WEAR BETWEEN HEAD AND TRUNNION OF STEM. PATIENT PRESENTED WITH ADVERSE LOCAL TISSUE REACTION TO METAL DEBRIS RESULTING IN PSEUDO TUMOR." SPOKE TO REP, HE STATED THE EXPLANTS ARE NOT BEING RETURNED AND NO ADDITIONAL INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9253089 ↗
• InjuryAug 16, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TRUNNIONOSIS. THE IMPLANTS WERE REVISED TO CONE/CONICAL RESTORATION MODULAR.

  Patient problems: Injury

  MAUDE report 8900622 ↗
• InjuryAug 15, 2019Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, TRUNNION WEAR AND A MODERATE AMOUNT OF BLACK TISSUE IN ONE AREA OF THE PATIENT WERE NOTED. IT WAS ALSO REPORTED THAT THE LINER WAS DAMAGED BY THE TRUNNION. A 36 +5 METAL HEAD, ACCOLADE STEM, AND POLY LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND ADM/ MDM LINER CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8897145 ↗
• InjuryMay 29, 2019Break; Break

  PATIENT HAD REVISION HIP SURGERY BECAUSE BROKEN PRIMARY STEM. UPDATE (B)(6) N019: REP PROVIDED AN OPERATIVE REPORT FOR THE (B)(6) 2019 REVISION WHICH CITES: "FAILED LEFT TOTAL HIP ARTHROPLASTY WITH COMPLETE RESORPTION OF THE TRUNNION AND SIGNIFICANT METALLOSIS DIFFUSELY ABOUT THE HIP COUPLED WITH SIGNIFICANTLY WEAK BONE SECONDARY TO THE METALLOSIS POLYETHYLENE WAS REMOVED WHICH HAD AN ABNORMAL COLOR TO IT SECONDARY TO THE METALLOSIS SIGNIFICANTLY WORN POSTERIORLY; HOWEVER, THERE WAS NO COMPLETE LOSS OF POLYETHYLENE." REP ALSO PROVIDED PRE- AND POST-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE: "BLACK TISSUE WAS NOTED IN THE PATIENT INTRA-OPERATIVELY, PSEUDO-TUMOR WAS REPORTED, NO ELEVATED ION LEVELS AND THERE WAS WEAR AND DISCOLORATION OF THE LINER REPORTED"

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8649406 ↗
• InjuryMay 20, 2019Degraded; Degraded

  INFORMATION RECEIVED FROM LEGAL DEPARTMENT "ALLEGEDLY THE SURGEON ¿REPLACED THE HEAD THAT WAS ORIGINALLY PLACED IN (B)(6) OF 2010, AS THERE WAS EVIDENCE OF WEAR. HE ALSO ADDED A FEMORAL CORTICAL STRUT TO THE PATIENT¿S HIP¿.

  Patient problems: Injury

  MAUDE report 8625898 ↗
• InjuryJan 8, 2019Use of Device Problem; Use of Device Problem

  THIS PI IS FOR THE INTRAOPERATIVE EVENTS (INTRAOPERATIVE FRACTURES) ON (B)(6) 2008. IN REVIEW OF A PRIMARY OPERATIVE REPORT FOR A PATIENT FOR PI (B)(4), THE OPERATIVE REPORT INDICATES: "...SEQUENTIAL BROACHING WAS THEN PERFORMED. A 3.5MM BROACH DEMONSTRATING PITCH CHANGE, THEREFORE, AN ACCOLADE TMZF 3.5 HIP STEM WAS IMPACTED IN THE PROXIMAL FEMUR. THIS IMMEDIATELY DROPPED BELOW THE LEVEL OF THE CALCAR IN APPEARANCE OF SUBSIDENCE. THE DECISION WAS MADE TO REMOVE THIS, FOLLOWED BY THE USE OF THE 4.0MM BROACH, WHICH ONCE AGAIN DEMONSTRATED PITCH CHANGE. A 4.0 HIP STEM WAS IMPACTED, ONCE AGAIN WITHOUT PITCH CHANGE, ONCE AGAIN SUGGESTING SIGNS OF SUBSIDENCE. IT SHOULD BE NOTED THAT THE 4.0 STEM WAS REMOVED AND THIS WAS BROACHED AGAIN TO ASSUME THE DEPTH OF THE BROACH. THERE WAS NOTED TO BE A POSTERIOR CORTICAL SPLIT ON THE CALCAR. THEREFORE, TWO SEPARATE 2.0MM DALL-MILES CABLES WERE PLACED AROUND THE PROXIMAL CALCAR REGION JUST ABOVE THE LESSER TROCHANTER WITH A NICE TIGHTENING IN THE CALCAR REGION. THE 4.0MM STEM WAS REPLACED...THE DECISION WAS MADE TO PERFORM ANOTHER X-RAY WITH THE IMPLANT REMOVED. ONCE AGAIN, ON AN AP OF THE PROXIMAL FEMUR A VERTICAL SPLIT IN THE PROXIMAL FEMORAL SHA

  Patient problems: Bone Fracture(s)

  MAUDE report 8229208 ↗
• InjuryOct 25, 2018Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  THE METAL HEAD WAS WORN OFF AND RUINED THE STEMS TRUNNION. UPDATE 16/OCTOBER/2018: REP LISTED THE FOLLOWING ADVERSE CONSEQUENCES: DELAY IN SURGERY, METALLOSIS, PSEUDOTUMOR.

  Patient problems: Edema; Inflammation; Injury; Reaction

  MAUDE report 8007110 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CONDITION AFTER IMPLANTATION OF AN ACCOLDADE SHAFT WITH V40 HEAD, DEVELOPMENT OF A LARGE PSEUDOTUMOR IN THE GROIN AREA DUE TO KNOWN CONE PROBLEMS IN THIS IMPLANT COMBINATION. SURGEON FORWARDED US THE FOLLOWING INFORMATION: IN SUMMARY, THE INCIDENT IS THE FOLLOWING SITUATION: (B)(6). IN 2007 IMPLANTATION OF A CEMENTLESS HIP ENDOPROSTHESIS (ACCOLADE, TRIDENT, METAL HEAD -0.5, ARTICLE NUMBERS ACCORDING TO SURGICAL REPORT). DEVELOPMENT OF LOCAL METAL INTOLERANCE WITH LARGE "PSEUDOTUMOR" / ARMD IN THE LEFT HIP WITH COMPRESSION OF THE ILIAC VEIN PRESUMABLY IN THE YEARS 2014 TO 2107 OF INCREASING SIZE. CURRENTLY 2017/2018 INCREASING LOCAL DISCOMFORT IN THE LEFT HIP JOINT. METAL VALUE INCREASE WITH COBALT IN WHOLE BLOOD 6,89 ¿G / L (REFERENCE RANGE 0,5-3,9 ¿G / L) AT NORMAL CHROMIUM VALUES ¿¿(0,62 ¿G / L AT REFERENCE VALUE 0,5 TO 4,0 ¿G / L IN WHOLE BLOOD). X-RAY INCREASING OSTEOLYSIS IN THE CUP AREA, IN CT AND MRI MRI , FORMATION OF A LARGE PSEUDOTUMOR BOTH IN THE AREA OF ¿¿THE OUTSIDE HIP MUSCLES AND IN THE RETROPERITONEUM AROUND THE ILIACUS MUSCLE. DUE TO INCREASING COMPLAINTS, THE RESECTION OF THE PSEUDOTUMOR WITH HEAD AND INLAY CHANGES TOOK PLACE ON (B)(6) 2018 (CLEAR CONICAL CORROSIO

  Patient problems: Discomfort; Edema; Injury; Osteolysis; Reaction

  MAUDE report 7797158 ↗