CERAMAX 1218-87-660Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295012559), received between Oct 4, 2017 and Nov 7, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ORIGINAL SURGERY DATE WAS SOMETIME IN 2014. THEY DO NOT HAVE RECORDS BUT THE SURGEON WAS ABLE TO GIVE US SIZES FROM HIS PRIMAL OP NOTE. THEY WILL NOT HAVE LOT # AS WELL. THE SURGEON SAID THE PT WAS COMPLAINING OF HIP PAIN. HIS ORIGINAL PLAN WAS TO DO A POLY SWAP AND HEAD EXCHANGE BUT ONCE IN THE SURGERY HE DEALT IT WOULD BE BETTER TO EXPLANT AND MAKE SURE IT WAS NOT INFECTED DUE TO WHAT HIS SOFT TISSUE LOOKED LIKE. HE EXPLANTED ALL COMPONENTS AND REPLACED WITH AN ANTIBIOTIC SPACER. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23497064 ↗
• MalfunctionAug 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON INSERTED A CERAMIC ON CERAMIC LINER INTO THE PATIENT. ON IMPACTION THE RIM OF THE CERAMIC ON CERAMIC LINER CRACKED AND FRAGMENTED. LINER WAS REMOVED AND ALL DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331226 ↗
• InjuryFeb 13, 2018Fitting Problem; Device Dislodged or Dislocated; Fitting Problem; Device Dislodged or Dislocated

  DER STATES THAT PATIENT DISLOCATED HIP AND WAS TAKEN BACK TO SURGERY TO PUT BACK IN PLACE. WHEN HE DISLOCATED A SECOND TIME SURGEON DECIDED TO TAKE THE PATIENT TO SURGERY TO REMOVE THE NEUTRAL CERAMIC LINER AND REPLACE WITH A MORE CONSTRAINED +4, 10 DEGREES. HE REMOVED THE LINER, CUP AND HEAD. HE REPLACED WITH A NEW CUP, LINER AND HEAD. CUP HAD TO BE REMOVED DUE THE INABILITY TO REMOVE THE LINER FROM THE CUP. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7266184 ↗
• MalfunctionDec 20, 2017Fracture; Fracture

  THE DER STATES THAT THE SURGEON POSITIONED CERAMIC LINER IN CUP AND WHILE IMPACTING LINER, HE NOTICED THAT THE LINER FRACTURED. THE ONLY REASON HE COMMENTED ON POSSIBLE DEFICIENCY WAS THAT HE HAD ANOTHER LINER THAT FRACTURED ON (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133544 ↗
• InjuryOct 4, 2017Fracture; Fracture

  DER STATES THAT THE SURGEON PLACED THE CERAMIC LINER IN THE CUP AND POSITIONED IT WITH THE ARD'S LINED UP. WHILE IMPACTING THE CERAMIC LINER IT CRACKED. THE SURGEON REMOVED ALL CHIPPED & BROKEN PIECES FROM THE PATIENT. HE WASHED OUT THE HIP AND PROCEEDED TO PUT IN ANOTHER LINER.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6914697 ↗