Accolade 6021-0637Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540510716), received between Jul 17, 2018 and Nov 8, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNIONOSIS. SURGEON ALSO REPORTED THAT THE SHELL WAS NOT ANTEVERTED PROPERLY, CAUSING IMPINGEMENT OF THE LINER AND STEM. AN ACCOLADE STEM, 40MM FEMORAL HEAD, AND LINER WERE REVISED TO COMPETITOR FEMORAL IMPLANTS AND A NEW STRYKER LINER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20636834 ↗
• InjuryOct 29, 2024Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  PATIENT HAD A RIGHT HIP REVISION DUE TO PAIN, NOISE IN HIP AND THE HEAD DISASSOCIATING FROM THE STEM.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20556590 ↗
• InjuryJun 9, 2024Degraded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2009, AND WAS IMPLANTED WITH AN LIFT V40 COCR FEMORAL HEAD AND ACCOLADE TMZF HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED ACUTE ONSET OF PAIN. REVISION OPERATIVE REPORT STATES "THE TRUNNION HAD BEEN COMPLETELY WORN DOWN TO A POINT AND THERE WAS A LOOSE METAL FRAGMENT ALSO IN THE ACETABULUM."

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19495760 ↗
• InjuryNov 1, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO TRUNNION WEAR AND DISSOCIATION OF THE HEAD FROM THE STEM. REP WAS NOT PRESENT FOR THE PROCEDURE. THE STEM, HEAD AND LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 15705704 ↗
• InjuryMar 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: "HEAD DISASSOCIATION FROM THE STEM. REVISION PROCEDURE TO REMOVE STEM AND RE-IMPLANT RESTORATION MODULAR STEM."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13647528 ↗
• InjuryAug 13, 2020Unstable; Unstable

  PATIENT WENT TO ER BECAUSE HE FELT A SNAP AND HIS HIP BECAME UNSTABLE. RADIOGRAPHS WERE TAKEN AND HIS HIP, RADIOGRAPHS REVEALED AN ISSUE WITH HEAD ALIGNMENT. THE PATIENT CONTACTED THE (B)(6) CLINIC FOR AN EXAMINATION. THE DOCTOR SAW THE PATIENT AND IMMEDIATELY SCHEDULED HIM FOR A HIP REVISION THE FOLLOWING DAY. WE REVISED THE HEAD, STEM AND THE ACETABULUM POLY. PATIENT HAD HIS ACCOLADE TMZF STEM REVISED. A NEW HEAD AND A NEW LINER WAS IMPLANTED. THE TRIDENT CUP WAS NOT DAMAGED AND WAS DEEMED STABLE DURING THE SURGERY.

  Patient problems: Injury

  MAUDE report 10400551 ↗
• InjuryFeb 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISASSOCIATION OF THE HEAD FROM THE STEM. THE STEM, HEAD, AND LINER WERE REVISED. REP PROVIDED A PRIMARY USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9667994 ↗
• InjuryJan 15, 2020Break; Break

  SPONTANEOUS FRACTURE OF THE HIP STEM PROSTHESIS AT THE TRANSITION FROM THE STEM CONE TO THE NECK OF THE STEM DUE TO MASSIVE METAL ABRASION INTRAOPERATIVELY MASSIVE METALOSIS IN THE AREA OF THE HIP CAPSULE, THE FEMUR CLOSE TO THE BODY AND UNDER THE ACETABULUM. LOOSENING OF THE ACETABULUM DUE TO ABRASION. FRACTURE OF THE PROSTHESIS NECK CAUSED THE PATIENT TO FALL AND THE BONE IN THE PROSTHESIS BEARING TO BREAK. THE PROSTHESIS WAS PROBABLY IMPLANTED IN 2009. SURGICAL REPORT NOT YET AVAILABLE DESPITE REQUEST. THE BROKEN HIP STEM PROSTHESIS WAS REMOVED.

  Patient problems: Fall; Inadequate Osseointegration; Inflammation; Injury; Reaction

  MAUDE report 9592709 ↗
• InjuryJun 24, 2019Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO TRUNNION DAMAGE. UPDATE: "THE HEAD DISASSOCIATED FROM THE STEM. SHELL WAS NOT REVISED. CONVERTED THE LINER TO MDM."

  Patient problems: Injury

  MAUDE report 8728263 ↗
• InjuryJan 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2008 AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 DUE TO ALLEGED HEAD DISASSOCIATION (HD).

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8273902 ↗
• InjuryOct 5, 2018Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  PATIENT WAS FIXING A DECK AND EXPERIENCED SEVERE PAIN IN HIS HIP AND COULD NOT MOVE WITHOUT PAIN. UPDATE 10/SEPTEMBER/2018: AS CITED IN "ADVERSE CONSEQUENCES DETAILS": PATIENT REQUIRED REVISION SURGERY. IT WAS REPEORTED THAT THE HEAD DISASSOCIATED FROM THE STEM. A CONSIDERABLE AMOUNT OF BLACK TISSUE WAS PRESENT IN THE JOINT. PRE-REVISION X-RAYS AND AN EXPLANT PICTURE WERE PROVIDED.

  Patient problems: Injury; Joint Dislocation; Pain; Reaction

  MAUDE report 7937984 ↗
• InjurySep 17, 2018Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. AFTER PATIENT COMPLAINT OF PAIN, HEAD WAS FOUND TO BE DISASSOCIATED FROM THE STEM (HEAD WAS SEATED IN LINER, LINER WAS FIXED IN SHELL). SURGEON TRIALED A NEW HEAD WHICH DIDN'T FIT. SURGEON THEN TRIED AN ADAPTOR SLEEVE WHICH ALSO DIDN'T SEAT PROPERLY. STEM WAS REVISED DUE TO EXCESSIVE WEAR OF THE TRUNNION. PATIENT WAS REVISED TO A 36 MM SIZE G ECCENTRIC INSERT WITH COMPETITOR STEM AND HEAD.

  Patient problems: Injury; Pain

  MAUDE report 7882613 ↗
• InjuryJul 17, 2018Device Dislodged or Dislocated; Unintended Movement; Insufficient Device Problem Information; Noise, Audible; Device Dislodged or Dislocated; Unintended Movement; Insufficient Device Problem Information; Noise, Audible

  ACCORDING TO THE SURGEON THE PATIENT HEARD A ¿POP¿ NOISE AND RIGHT AWAY SET AN APPOINTMENT. THE SURGEON HAD XRAYS TAKEN OF THE RIGHT HIP AND NOTICED THE FEMORAL HEAD WAS SEATED ON ACCOLADE TMZF STEM IN AN INCORRECT POSITION. THE SURGEON REVIEWED X RAYS WITH HIS COLLEAGUES AND THEY AGREED THEY SHOULD REVISE THE RIGHT HIP. HIP WAS REVISED ON WED (B)(6) 2018 WITH STRYKER MODULAR HIP REPLACEMENT SYSTEM.

  Patient problems: Injury

  MAUDE report 7695046 ↗