Accolade 6077-0335Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327021196), received between Jul 19, 2018 and Apr 9, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2020Corroded; Corroded

  IT WAS REPORTED THROUGH A MEDWATCH 5093292: "PATIENT ID:[...]; ON [...] 2006, HE UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY WITH STRYKER (HOWMEDICA) COMPONENTS, UNCEMENTED PSL 54 OD SOCKET, 32MM CROSSFIRE POLYETHYLENE INSERT. ACCOLADE HFX STEM SIZE 3 (REF #6077-03358), AND A 32MM +4 LFIT ANATOMIC V40 HEAD (REF #6077-0335) AND A 32MM +4 LFIT ANATOMIC V40 HEAD (REF #6260-5-232). IN [...] OF 2016, HE HAD A SUDDEN EPISODE OF WEAKNESS IN THE RIGHT LEG, WHICH CONCERNED HIM AND PROMPTED EVALUATION OF HIS RIGHT HIP REPLACEMENT. IN THE YEAR PRECEDING THAT EPISODE, HE HAD BEEN EXPERIENCING A SIGNIFICANT TREMOR OF HIS HANDS, FATIGUE AND REDUCED STAMINA. METAL SUPPRESSION MRI OF RIGHT HIP ON [...] 2016 SHOWED A SMALL PSEUDOTUMOR JUST SUPERIOR TO THE FEMORAL NECK WITH INVOLVEMENT OF THE GLUTEUS MEDIUS TENDON. FDG PET BRAIN SCAN AND NEURO Q ANALYSIS SHOWED ABNORMAL HYPOMETABOLISM IN FOCAL AND GENERALIZED DUSTER REGIONS IN A PATTERN COMPATIBLE WITH CHRONIC TOXIC ENCEPHALOPATHY. ON [...] 2016, SERUM/ PLASMA COBALT LEVEL WAS 5.8 MCG/L AND CHROMIUM WAS 1.7MCG/L. ON [...] 2016, RIGHT HIP WAS REVISED TO A ZIMMER WAGNER STEM 190 BY 14MM, TRIDENT X3 32ID LATERALLY OFFSET LINER, A 32MM DELTA CERAMIC +0 HEA

  Patient problems: Injury; Reaction; Weakness

  MAUDE report 9944068 ↗
• InjuryMar 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH (MW5092198) "ON 2010, THE PT RECEIVED A LEFT TOTAL HIP ARTHROPLASTY. THE LEFT HIP IMPLANT CONSISTS OF A STRYKER ACCOLADE COBALT-CHROME HFX STEM WITH A 36MM +5 COCR HEAD, A 50 PSL, SOCKET AND 36 INTERNAL DIAMETER X3 POLYETHYLENE LINER AND A SINGLE ACETABULAR SCREW. ON 2014, COBALT URINE LEVEL WAS 19 MCG/L AND SERUM COBALT WAS 4.0 MCG/L. AROUND THE SAME TIME, THE PT ALSO DEVELOPED UNCHARACTERISTIC CRANKINESS, MEMORY PROBLEMS, VISION PROBLEMS, WORD FINDING ISSUES. HER NEUROLOGICAL PROBLEMS WERE SO CONCERNING THAT SHE SOUGHT NEUROPSYCHOLOGICAL EVALUATION. THE PT ALSO NOTED HAVING INCREASED LATENCY TO SLEEP AND DURING THE SAME TIME THE PT ALSO EXPERIENCED INCREASING NUMBNESS OF BOTH HANDS MORE SO THE RIGHT THAN THE LEFT HAND. ON 2015, PT UNDERWENT AN ECHOCARDIOGRAM WHICH SHOWED GRADE 1 DIASTOLIC DYSFUNCTION, MILD LEFT VENTRICULAR HYPERTROPHY, AND A SLIGHTLY INCREASED RIGHT VENTRICLE PRESSURE. ON 2015, THE LEFT HIP WAS REVISED DUE TO ELEVATED COBALT LEVELS IN BLOOD AND URINE AND NEW NEUROLOGICAL PROBLEMS SUGGESTING POSSIBLE ARTHROPLASTY COBALT TOXICITY. THE SUPERFICIAL PERIPROSTHETIC TISSUE APPEARED INFLAMED AND EDEMATOUS. FROZEN SECTION OF LEFT HIP TISSU

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9775530 ↗
• InjuryJun 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT'S LEFT HIP WAS IMPLANTED WITH THE (ABOVE) LISTED COMPONENTS ON (B)(6) 2009 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE EXPERIENCED SIGNIFICANT PAIN IN HER LEFT HIP, LAB TESTING OF BLOOD AND URINE SHOWED THE PRESENCE OF ELEVATED COBALT AND CHROMIUM AND RADIOLOGY STUDIES SHOWED THE PRESENCE OF PSEUDO TUMORS. IT IS ALLEGED THAT DURING THE REVISION SURGERY, HER SURGEON FOUND SIGNS OF METALLOSIS, WHICH INCLUDED BLACK CORROSION DEBRIS, DAMAGED HIP LIGAMENTS, THE PRESENCE OF PSEUDO TUMORS AND METAL DEBRIS AT THE HIP/NECK JUNCTION.

  Patient problems: Edema; Inflammation; Injury; Pain; Reaction

  MAUDE report 8699363 ↗
• MalfunctionJul 19, 2018Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  DURING A HEMIARTHROPLASTY FOR A HIP FRACTURE AT (B)(6) HOSPITAL IN (B)(6) THE SURGEON OPENED A SIZE 3 ACCOLADE HFX STEM AND NOTICED SMALL, WHITE PARTICLES ON THE NECK OF THE STEM. DR. (B)(6) COMMENTED THAT THE NECK OF THE STEM WAS NOT IN THE PROTECTIVE FOAM WHEN HE OPENED THE STEM ON THE BACK TABLE. THIS ITEM WAS SET ASIDE ON THE BACK TABLE AND NOT IMPLANTED. A SECOND STEM WAS OPENED AND IMPLANTED INTO THE PATIENT. UPDATE (B)(6) 2018: REP REPORTED THAT THE DEVICE WAS IN PROTECTIVE FOAM BUT THE NECK WAS NOT PROPERLY SEATED, PRESSING IT AGAINST THE PLASTIC TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7703939 ↗