Alumina 6565-0-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540402141), received between Feb 10, 2020 and Apr 3, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K023901, K173499, K243784); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Noise, Audible

  THE FOLLOWING INFORMATION WAS PROVIDED: HIP REVISION OF CERAMIC ON CERAMIC HIP DUE TO PATIENT COMPLAINT OF "SQUEAKING." LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24779753 ↗
• MalfunctionFeb 26, 2024Fracture; Fracture

  ON JANUARY 29, 2024, AN ADVERSE EVENT OCCURRED DURING THE IMPLANTATION OF THE CERAMIC ALUMINA HEAD REF: 6565-0-036, SN:(B)(6). WHILE ADJUSTING THE HIP JOINT AND CHECKING THE PROPER ROTATION OF THE JOINT ( ABDUCTION, ADDUCTION OF THE HIP JOINT), THE ALUMINA HEAD THAT HAD ALREADY BEEN IMPLANTED ON THE ACCOLADE II STEM BROKE. SINCE THE SAME HEAD ( ALUMINA IN SIZE 36) WAS AVAILABLE AT THE STRYKER IMPLANT COMMISSARY IN THE OPERATING THEATER, THE PROCEDURE WAS COMPLETED WITHOUT A PROBLEM AND AT THE RIGHT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785513 ↗
• InjuryOct 5, 2020Insufficient Device Problem Information; Noise, Audible; Insufficient Device Problem Information; Noise, Audible

  REVISION SURGERY ON STRYKER IMPLANTS. REPLACED WITH STRYKER STEM AND FEMORAL HEAD AND DEPUY CUP AND INSERT ON (B)(6) 2020. PATIENT COMPLAINT OF PAIN AND SQUEEK / CLUNKINESS. SIGNS OF TRUNIONOSIS AND IMPINGEMENT NOTED BY SURGEON. STRIPE WEAR ON CERAMIC HEAD. LINER RIM DAMAGED BY WEAR FROM STEM. REVISION ON PREVIOUS PRIMARY SURGERY.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 10631086 ↗
• InjurySep 22, 2020Degraded; Degraded

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE IMPLANTS WERE REMOVED AFTER 1 YEAR AND 4 MONTHS IMPLANTED IN THE PATIENT DUE TO WEAR. UPDATE: ACCORDING TO DR, "PRIOR TO THE INCIDENT THERE WERE NO ACCIDENTS WHAT'S OVER OR OTHER SURGERIES. THE PATIENT PERFORMED REGULAR DAILY ACTIVITY (NO SPORTS) INCLUDING WORK IN HIS RESTAURANT. THE PATIENT FIRST CAME TO SEE ME ON (B)(6) IN 2019 FOR THE NOISE HE NOTICED WHILE WALKING...I SAW THE PATIENT AGAIN ON (B)(6) IN 2019 FOR NOW PAINFUL MOVEMENT OFT HE LEFT HIP AND AN X-RAY WAS PERFORMED...THE REVISION SURGERY FORT HE LEFT HIP COULD BE PERFORMED AS PLANNED ON (B)(6) IN 2020...((B)(6) 2020) THERE WAS, AS EXPECTED, A STRONG METALLOSIS OFT HE SURROUNDING SOFT TISSUE AT THE LEFT HIP. CUP, PE AND FEMORAL HEAD WERE REMOVED ENTIRELY FOR MATERIAL TESTING. AFTER TAKING SEVERAL BONE AND SOFT TISSUE SAMPLES OF THE SUPERFICIAL AND DEEP LAYERS OF TISSUE, AN EXTENSIVE BONE AND SOFT TISSUE DEBRIDEMENT AND JET-LAVAGE WERE PERFORMED. THE REPLACEMENT CUP COULD BE POSITIONED WITHOUT PROBLEMS AND WAS FIXED WITH ADDITIONAL CANCELLOUS BONE SCREWS. AFTER INSERTING THE PE INSERT AND TESTING FOR CORRECT PLACEMENT AND STABILITY, A CERAMIC V40 HEAD 36MM WAS USED AND JOINT

  Patient problems: Failure of Implant; Pain

  MAUDE report 10566697 ↗
• InjuryFeb 10, 2020Fracture; Insufficient Device Problem Information; Fracture; 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 LEFT HIP ON OR ABOUT (B)(6) 2005 AND THE FEMORAL HEAD WAS EXPLANTED ON (B)(6) 2013. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 9689077 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023901, K173499, K243784. One submission often covers many models, so check the product and lot details in each record.

• Z-0314-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
• Z-0313-2022 · Oct 15, 2021 · Open, Classified
  28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028