CERAMAX 1218-89-648Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295012658), received between Mar 19, 2020 and May 29, 2026 — classified as 2 injuries, 4 malfunctions.

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

• MalfunctionMay 29, 2026Fracture

  IT WAS REPORTED THAT CERAMAX LINER WAS IMPLANTED AND SHATTERED UPON IMPACTION. DOE: (B)(6) 2026. FOLLOW UP WITH REPORTER: A. AFFECTED SIDE WAS THE LEFT SIDE. B. YES, IT SHATTERED INTO NUMEROUS PIECES. ALL FRAGMENTS WERE COLLECTED AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334496 ↗
• MalfunctionJun 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, THE CERAMAX CERAMIC INSERT BROKE INTO MULTIPLE PIECES WHEN IMPACTED INTO THE ACETABULAR SHELL. THE SURGEON WAS UNABLE TO USE THE LINER, AND IMPLANTED A POLY LINER IN PLACE OF THE BROKEN CERAMIC LINER. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22182840 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. THE SURGEON DID A WASHOUT WITH LINER AND HEAD EXCHANGE. THE HOSPITAL RETAINED THE COMPONENTS FOR THE PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19656963 ↗
• InjuryOct 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH A FRACTURED CERAMAX LINER. IT WAS CONFIRMED INTRAOPERATIVELY. THE CERAMIC PIECES OF THE LINER APPEARED TO BE MOSTLY FROM THE EQUATOR PORTION OF THE LINER WERE RETRIEVED FROM SOFT TISSUE. THE MAJORITY OF THE LINER WAS STILL IN ONE PIECE AND WAS EXTRACTED WITH THE SUCTION CUP PROVIDED IN THE CERAMAX INSTRUMENTATION. THE WOUND WAS THOROUGHLY DEBRIDED. A PINNACLE ALTRX LINER ALONG WITH A NEW BIOLOX TS CERAMIC HEAD WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17876856 ↗
• MalfunctionJan 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE LINER BROKE WHEN THE SURGEON WAS PUTTING IT IN. HE HAD TO PULL THE CUP OUT AND DAMAGED THE CUP WHILE TRYING TO GET THE LINER OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13357837 ↗
• MalfunctionMar 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE LINER BROKE AT THE RIM. THE REMAINING LINER BECAME STUCK IN THE SHELL. THE SHELL AND THE LINER HAD TO BE REMOVED TOGETHER. ON THE BACK TABLE, THE SHELL AND THE LINER WERE STILL STUCK TOGETHER. A NEW CUP AND A NE LINER WERE USED TO COMPLETE THE CASE. IT WAS BELIEVED THAT THE LINER MAY BE DEFECTIVE. NO HARM TO THE PATIENT OCCURRED, BUT THERE WAS A FIVE-MINUTE SURGICAL DELAY. DOE: (B)(6) 2020. RIGHT HIP

  Patient problems: No Code Available

  MAUDE report 9856481 ↗