CERAMAX 1218-87-658Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295012542), received between Aug 18, 2017 and Aug 2, 2023 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER WAS BEING INSERTED INTO THE PINNACLE SECTOR GRIPTION CUP WITH THE KINCISE GUN WHEN THE LINER FRACTURED AROUND THE RIM OF THE IMPLANT. ALL PIECES WERE RETRIEVED AND A PINNACLE DUAL MOBILITY CONSTRUCT WAS USED. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 17443892 ↗
• InjuryJan 24, 2023Fracture; Fracture

  PATIENT REVISED DUE TO CERAMIC ON CERAMIC HAD A CATASTROPHIC FAILURE AFTER THE PATIENT WAS RUNNING WIND SPRINTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16232950 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6), 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 13975276 ↗
• MalfunctionDec 3, 2020Fracture; Fracture

  DOI: UNKNOWN, DOR: (B)(6) 2020 LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 10941387 ↗
• MalfunctionOct 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2020, THEY HAD USED A 36/58 CERAMIC LINER TO IMPLANT INTO THE PATIENT. AS THE SURGEON WAS IMPACTING THE CERAMIC LINER INTO THE PATIENT, THE LINER EDGE CHIPPED OFF. HE PROCEEDED TO REMOVE ALL PIECES OF THE CERAMIC THAT HAD CHIPPED OFF. AFTER THE CHIPPED PIECES WERE OUT OF THE PATIENT HE THEN TOOK THE LINER OUT, AND DID A DEEP WASHOUT TO ENSURE NO OTHER PIECES WERE IN THE PATIENT. WE THEN USED A REGULAR ALTREX LINER FOR THE PATIENT INSTEAD OF THE CERAMIC LINER. ALL CHIPPED PARTS OF THE LINER WERE EXPLANTED OUT OF THE PATIENT, AND THROWN AWAY. THE MAIN PART OF THE LINER WAS WASHED AND SENT BACK TO OUR OFFICE. THE SURGEON DID CONFIRM THAT THERE WAS NO CERAMIC DEBRIS LEFT IN THE PATIENT. DOE: (B)(6) 2020. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10749751 ↗
• InjuryOct 19, 2020Fracture; Fracture

  FRACTURED CERAMIC LINER AFTER 1 YEAR OF IMPLANTATION. THE SURGEON WOULD LIKE THE LINER ANALYSED BY DEPUY FOR ANY REASON THIS MAY HAVE OCCURRED. HE HAS LOOKED AT IMMEDIATE POST-OP XRAYS AND CAN SEE THE CERAMIC LINER IS NOT FULLY SEATED. IT WENT ON TO FRACTURE.

  Patient problems: No Code Available

  MAUDE report 10698042 ↗
• MalfunctionJul 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMAX CERAMIC ACETABULAR LINER CRACKED IN MULTIPLE PIECES AFTER IMPACTING INTO ACETABULAR SHELL. LEFT SIDE.

  Patient problems: Not Applicable

  MAUDE report 10251901 ↗
• InjuryAug 23, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMAX LINER 58 MM CRACKED UPON IMPACTION. PIECES WERE REMOVED. SURGEON NOTICED DAMAGE TO CUP. REMOVED SCREWS AND CUP. REPLACED WITH LARGER CUP AND SCREWS. DOE- (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7809430 ↗
• InjuryAug 18, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE HIP WAS REVISED AND FOUND DEPUY CERAMIC LINER HAD BROKEN INTO PIECES.

  Patient problems: No Information

  MAUDE report 6804049 ↗