Alumina 6565-0-232Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540390509), received between Oct 15, 2018 and Feb 17, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Noise, Audible” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: THE MPS REPORTED THAT: "I AM REPORTING A MEDICAL DEVICE VIGILANCE CASE FOLLOWING A MAKO PTH ON THE LEFT SIDE PERFORMED ON (B)(6) 2023. AFTER FALLING OUT OF BED, THE PATIENT RETURNED A FEW DAYS AGO AND THE SCAN SHOWED THAT THE ALUMINA CERAMIC HEAD HAD EXPLODED." "THE REVISION IS SCHEDULED FOR TODAY. WE WILL KEEP THE HEAD AND THE PIECES TO SEND THEM BACK TO THE MANUFACTURER AND GET FEEDBACK ON THE MATERIAL ANALYSIS."

  Patient problems: Fall

  MAUDE report 24362417 ↗
• InjuryNov 25, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible; Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible

  PATIENT GOT A RIGHT HIP REVISION DUE TO ¿SQUEAKING¿ COMPLAINTS. PATIENT COMPLAINT OF GRINDING, POPPING FEELING AND AUDIBLE SQUEAK AND GRINDING. PATIENT ALSO EXPERIENCING PAIN. CUP AND LINER WERE WELL FIXATED. HEAD EASILY REMOVED FROM TRUNNION. NO MARKED STRIPING ON CERAMIC LINER OR OUTER HEAD - BUT BROWN DISCOLOURATION INSIDE HEAD. HEAD LOOSE ON TRUNNION. RUST MARKS ON CUP RIM. FEMORAL STEM UNREMARKABLE, FIXATED AND RETAINED.

  Patient problems: Pain

  MAUDE report 10903163 ↗
• InjuryJan 30, 2020Fracture; Fracture

  BROKEN TRUNNION ON EXETER 37.5MM NO 3 STEM. PATIENT WAS REVISED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9648124 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR REVISION DUE TO DISLOCATION; PATIENT CALLED STATED HE HAD A LEFT HIP REPLACEMENT DONE ON (B)(6) 2007. HE STATED HE HAD A DISLOCATION A FEW DAYS AFTER HIS SURGERY, AND WAS REVISED ON (B)(6) 2007. PATIENT DID NOT SPECIFY IF THE HEAD CAME OUT OF THE LINER OR THE LINER CAME OUT OF THE SHELL. HE REPORTED THAT HE IS CURRENTLY FEELING PAIN AND DISCOMFORT AND WOULD LIKE TO KNOW IF HIS IMPLANTS ARE PART OF A RECALL.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9079439 ↗
• InjuryJan 22, 2019Material Deformation; Noise, Audible; Material Deformation; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT, "HAD A TRIDENT HEMISPHERICAL RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2006." IT IS FURTHER REPORTED THAT, "ON (B)(6) 2007, THE PATIENT UNDERWENT REVISION OF THE RIGHT HIP." PER REVIEW OF MEDICAL RECORDS [...] "ON (B)(6) 2007 IT WAS NOTED SHE "BEGAN TO NOTICE SQUEAKING ON RIGHT HIP SINCE (B)(6) 2007, INCREASING, AND NOW GRINDING-LIKE AND RUSTY DOOR CLOSING".[...]IT WAS NOTED THAT HER HIP "READILY SQUEAKS AS SHE WALKS THROUGH THE OFFICE" AND THAT THE "SQUEAK IS UNACCEPTABLE TO HER''..."ON (B)(6) 2007 A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR WHICH AN OPERATIVE REPORT DESCRIBES REGIONAL ANESTHESIA AND A POSTEROLATERAL APPROACH FOR A DIAGNOSIS OF ASEPTIC FAILURE DUE TO BEARING SURFACE WEAR AND IMPLANT FAILURE. DURING SURGERY THE "CERAMIC HEAD HAD A LARGE FOCUS OF STRIPE WEAR". THE ACETABULAR COMPONENT WAS "NOTED TO BE MODERATELY VERTICAL AND SEVERELY ANTEVERTED AT AROUND 60°". THREE SCREWS WERE REMOVED AFTER THE LINER AND THE CUP WAS REMOVED WITH THE IMPLEX ACETABULAR OSTEOTOME DEVICE WITH MINIMAL EVIDENCE OF BONE INGROWTH. "

  Patient problems: Injury

  MAUDE report 8267696 ↗
• InjuryOct 15, 2018Noise, Audible; Noise, Audible

  SURGEON REMOVED A CERAMIC HEAD AND CERAMIC LINER AND REPLACED WITH A UNIVERSAL BIOLOX HEAD AND POLYETHYLENE LINER. IMPLANTS THAT WERE NOT REMOVED ARE AS FOLLOWS: 6021-0435, LOT 13131801. 542-11-54F, LOT 31334103. UPDATE 19/SEPTEMBER/2018: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT HAD PAIN AND HEARD A CLICKING. NO PROBLEMS WERE EVIDENT UPON VISUAL EXAMINATION OF THE REMOVED COMPONENTS.

  Patient problems: Injury; Pain

  MAUDE report 7967509 ↗

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