Accolade 6020-0537Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540510570), received between Jun 20, 2018 and Mar 19, 2026 — classified as 23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Detachment of Device or Device Component

  PATIENT HAD EMERGENCY REVISION SURGERY DUE TO A HEAD DISASSOCIATION IN HIS RIGHT HIP. ON (B)(6) 2025, THE PATIENT REPORTED STANDING UP FROM A COUCH WHEN HE EXPERIENCED SEVERE PAIN AND WAS UNABLE TO WALK. PATIENT IS SEEKING COMPENSATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 24636623 ↗
• InjuryOct 28, 2025Degraded; Degraded

  PATIENT HAD HIP SURGERY 10 YEARS AGO. HE CONTACTED STRYKER TO INQUIRE WHO IS GOING TO PAY HIS HOSPITAL BILLS FOR HIS MRI & BLOODWORK OF WHICH HE HAS METALLOSIS. HE IS DISABLED & HAS MEDICARE. PATIENT STATED HE WAS WALKING PRIOR TO SURGERY AND NOW IS A QUADRAPLEGIC (BROKE HIS NECK MANY YEARS PRIOR). HE WAS TOLD HE NEED ANOTHER MRI AND REVISION SURGERY TO REPLACE CERAMIC HEAD & CUP. UNABLE TO OBTAIN AN ANSWER FROM THE SURGEON REGARDING BILL PAYMENT. HE WOULD LIKE TO KNOW WHAT ARE HIS ALTERNATIVES TO THIS SITUATION.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23404112 ↗
• InjuryApr 8, 2025Corroded; Degraded; Detachment of Device or Device Component; Corroded; Degraded; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 21795505 ↗
• InjuryFeb 6, 2025Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT ANATOMIC V40 FEMORAL HEAD AND #5 ACCOLADE TMZF STEM. ALLEGEDLY SHE DEVELOPED METALLOSIS ABOUT THE HIP AND HAS FRACTURED HER FEMORAL HEAD OFF OF THE TRUNNION. SHE WAS REVISED ON (B)(6) 2024.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 21321413 ↗
• InjuryApr 16, 2024Fracture; Fracture

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2009 AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND AN ACCOLADE TMZF HIP STEM. HE WAS REVISED ON (B)(6) 2021 DUE TO ALLEGED FRACTURED TRUNNION AND PARTIAL DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19122656 ↗
• InjuryJul 18, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2011 AND WAS REVISED ON (B)(6) 2022. DURING THE REVISION THE SURGEON NOTED "¿ THERE WAS A SIGNIFICANT AMOUNT OF BLACK METALLOSIS FLUID ENCOUNTERED. AN EXTENSIVE DEBRIDEMENT OF ALL METAL DEBRIS WAS PERFORMED AND IT WAS FOUND THAT HIS TRUNNION WAS COMPLETELY DESTROYED."

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 15046515 ↗
• InjurySep 30, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. THE PATIENT HAD FALLEN AND THE HEAD DISASSOCIATED FROM THE STEM. INTRAOPERATIVELY, THE SURGEON NOTICED THAT THERE WAS A LOT OF WEAR AROUND THE TRUNNION. REP NOTED THAT "THE TIP OF THE TRUNNION WAS GONE." REP HAS THE IMPLANTS FOR RETURN.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 12554364 ↗
• InjuryMay 19, 2021Material Erosion; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Erosion; Detachment of Device or Device Component; Insufficient Device Problem Information

  PATIENT HAD HIP REPLACEMENT INSERTED IN 2006. WAS DOING FINE UNTIL 2 WEEKS AGO AND CONSULTED WITH THE DR. WHO DID REVISION HIP SURGERY YESTERDAY UPDATE PER PER FORM: " PATIENT SAID HE FELT ACUTE CHANGE ON HIS HIP PER DESCRIPTION FROM OP-NOTES." *UPDATE ON (B)(6) 2021 PER CLINICIAN REVIEW: "[...] THE EVENT A REVISION SURGERY WAS CONFIRMED VIA THE OP NOTE. THE REVISION WAS FOR HEAD-STEM DISENGAGEMENT. TRUNNION WEAR AND METALLOSIS NOTED AT REVISION. [...]

  Patient problems: Failure of Implant; Pain

  MAUDE report 11847864 ↗
• InjuryJan 5, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONS.

  Patient problems: Inflammation; No Information

  MAUDE report 11118306 ↗
• InjuryNov 10, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SEVERE WEAR OF THE TRUNNION AND NOTCHING ON THE MEDIAL SIDE OF THE STEM CAUSED BY THE SHELL. INTRA-OPERATIVELY, METALLOSIS WAS NOTED. THE STEM, HEAD AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Inflammation

  MAUDE report 10819615 ↗
• InjuryMay 18, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. INTRA-OPERATIVE OBSERVATIONS REPORTED TO THE REP: A MODERATE AMOUNT OF BLACK TISSUE, THE TRUNNION WAS WORN AND CRACKED OFF. THE LINER WAS DISCOLORED. THE PORTION OF THE STEM INSIDE THE HEAD WAS REMOVED WITH DIFFICULTY.

  Patient problems: Inflammation; Injury

  MAUDE report 10065859 ↗
• InjuryFeb 6, 2020Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  RECALLED V40 METAL HEAD INVOLVED PATIENT PAIN.

  Patient problems: Injury; Pain

  MAUDE report 9676767 ↗
• InjuryOct 16, 2019Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE TMZF STEM HAD MAJOR TRUNNIONOSIS AND THE PATIENT REQUIRED REVISION SURGERY.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9197366 ↗
• InjurySep 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, AN EXTREME AMOUNT OF TRUNNION WEAR WAS NOTED, AND DAMAGE TO THE RIM OF THE LINER FROM THE STEM. THE SHELL WAS WELL-FIXED AND WELL- POSITIONED AND WAS NOT REVISED. THE PATIENT WAS REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND MDM/ADM LINER CONSTRUCT. PRIMARY IMPLANTATION OCCURRED WITHIN THE REVISION FACILITY'S HOSPITAL NETWORK BUT THE EXACT HOSPITAL IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8955492 ↗
• InjuryAug 23, 2019Break; Break

  NECK OF FEMORAL PROSTHESIS BROKE.

  Patient problems: Injury

  MAUDE report 8925092 ↗
• InjuryJun 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. INTRA-OPERATIVELY, AN EXTREME AMOUNT OF BLACK TISSUE AND DISCOLORATION OF THE LINER WERE NOTED. PATIENT WAS REVISED TO A COMPETITOR STEM AND HEAD WITH A STRYKER LINER. THE SHELL WAS NOT REVISED.

  Patient problems: Injury; Reaction

  MAUDE report 8715883 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, EXCESSIVE BLACK TISSUE, SIGNIFICANT TRUNNION WEAR, AND CORROSION WERE NOTED. PATIENT'S ENTIRE HIP CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED AS THE SURGEON ALSO SUSPECTED INFECTION (INFECTING MICROORGANISM NOT REPORTED TO REP).

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 8517932 ↗
• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  HIP REVISION OF ACCOLADE TMZF STEM WITH DISASSOCIATED HEAD.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8358185 ↗
• InjuryOct 22, 2018Degraded; Degraded

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. AS REPORTED BY REP: "THE FEMORAL HEAD AND FEMORAL STEM NECK TRUNION IS WORN. THE FEMORAL HEAD DISASSOCIATED".

  Patient problems: Injury; Reaction

  MAUDE report 7991578 ↗
• InjuryOct 11, 2018Degraded; Degraded

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO SUSPECTED TRUNNIONOSIS. REP WAS NOT PRESENT FOR PROCEDURE. NO PATIENT COMPLAINTS, PRE-OPERATIVE DIAGNOSES, REASON FOR SUSPICION OF TRUNNIONOSIS, OR INTRA-OPERATIVE FINDINGS WERE REPORTED TO THE REP. PRIMARY AND REVISION OPERATIVE NOTES WERE PROVIDED. PATIENT'S STEM, FEMORAL HEAD, LINER, AND SHELL WERE REVISED. REASON FOR SHELL REVISION WAS NOT REPORTED TO THE REP.

  Patient problems: Injury

  MAUDE report 7958740 ↗
• InjuryOct 8, 2018Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT REQUIRED A HIP REVISION. UPDATE; PER RECEIVED IMAGES, IT APPEARS THE TRUNNION IS WORN AND HEAD DISLOCATED.

  Patient problems: Injury

  MAUDE report 7944551 ↗
• InjurySep 11, 2018Break; Degraded; Material Deformation; Break; Degraded; Material Deformation

  AS REPORTED: "PATIENT HAS PAIN AND SHORTENING OF HIP. COMPLAINS HIP GAVE OUT". PRE-REVISION X-RAYS REVEAL THE HEAD DISASSOCIATED FROM THE STEM AND SHOW AT LEAST THE HEAD ROTATED WITHIN THE SHELL OR LINER. EXPLANT PICTURES SHOW THAT THE TRUNNION WAS WORN AT THE TIP, AND BROKEN OFF OF THE STEM. REVISION IMPLANTS ARE A 44MM G POLY LINER, 44 +0 LFIT HEAD, AND A SIZE 6 35 X 111MM STEM.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7864592 ↗
• InjuryJun 20, 2018Corroded; Degraded; Disassembly; Corroded; Degraded; Disassembly

  IT WAS REPORTED THAT ON (B)(6) 2018, DR. (B)(6) PERFORMED A REVISION OF AN ACCOLADE STEM WITH A DISLOCATED FEMORAL HEAD COMPONENT AS VISIBLE BY PREOP X-RAY. UPDATE PER MED REVIEW: CUP MALPOSITION IN NEAR ABSENT ANTEVERSION HAS CONTRIBUTED TO AN OVERLOAD CONDITION IN THE ARTHROPLASTY, ESPECIALLY NEAR THE TRUNNION SECTION CAUSING SECONDARY CORROSION BETWEEN FEMORAL HEAD AND STEM TAPER LEADING TO PROGRESSIVE METAL SUBSTANCE LOSS WITH METALLOSIS IN THE JOINT SPACE, LOSS OF TAPER LOCK AND ULTIMATELY DISASSOCIATION BETWEEN STEM TRUNNION AND FEMORAL HEAD REQUIRING REVISION. ADDITIONALLY, THERE IS OSTEOLYSIS AROUND THE PROXIMAL STEM SECTION ALTHOUGH THE STEM REMAINS WELL FIXED IN THE MORE DISTAL PARTS. ALSO AROUND THE CUP IS OSTEOLYSIS EVIDENT, ESPECIALLY AROUND THE SUPPLEMENTAL SCREW FIXATION ALTHOUGH ALSO THE CUP STILL APPEARS STABLE IN THE BONE NEAR THE PERIPHERY.

  Patient problems: Injury; Osteolysis; Reaction

  MAUDE report 7620182 ↗