CERAMAX 1218-87-652Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295012511), received between Jul 26, 2017 and May 5, 2026 — classified as 19 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (21 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT THE 52/36 CERAMIC LINER BROKE WHILE IT WAS IMPACTING INTO THE CUP. DOE-(B)(6) 2026. AFFECTED SIDE-UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 25086188 ↗
• MalfunctionMar 30, 2026Fracture; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP. DURING IMPACTION OF THE CERAMIC LINER, THE LINER DID NOT SEAT FLUSH OR LEVEL WITH THE ACETABULAR CUP. THE SURGEON REMOVED THE LINER TO SEAT PROPERLY. DURING REMOVAL OF THE LINER, THE CERAMIC LINER BROKE. A NEW LINER WAS IMPLANTED. DOE- (B)(6) 2026. AFFECTED SIDE- LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728478 ↗
• MalfunctionNov 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER FRACTURED DURING INSERTION. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES. ALL THE FRACTURED CERAMIC PIECES WERE REMOVED. THERE WAS NO ALLEGATION AGAINST THE PINNACLE CUP. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583909 ↗
• MalfunctionJul 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS WAS A PRIMARY TOTAL WITH THE SURGEON. SURGEON WANTED TO USE A PINNACLE GRIPTION CUP WITH A CERAMAX LINER. HE IMPLANTED THE CUP WITHOUT ISSUE BUT WHILE IMPLANTING THE CERAMAX LINER, IT CRACKED AND A PIECE OF THE RIM CAME OFF. SURGEON RETRIEVED THAT PIECE OF THE CERAMIC LINER. SINCE THE LINER WAS DAMAGED, SURGEON DECIDED TO REMOVE THE PINNACLE CUP AS WELL. THE CASE WAS COMPLETED WITH A COMPETITOR CUP AND LINER. DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587182 ↗
• InjuryMay 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A FRACTURED 52 BY 36 CERAMAX INSERT.

  Patient problems: Insufficient Information

  MAUDE report 22051228 ↗
• InjuryMar 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S HEAD AND LINER WEE REVISED DUE TO PAIN. THE LINER HAD A CHIP OUT OF IT. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE : LEFT HIP.

  Patient problems: Pain

  MAUDE report 18970358 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER CRACKED ON THE EDGE WHILE IMPACTING INTO THE CUP. LINER HAD TO BE TAKEN OUT AND REPLACED. THERE WAS A SURGICAL DELAY OF 15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 17119177 ↗
• InjuryJan 12, 2022Fracture; Fracture

  THE PATIENT WAS REVISED DUE TO THE CERAMIC LINER BROKE. THE ORIGINAL SURGERY WAS DONE (B)(6) 2021. IT WAS REPLACED WITH A NEW FEMORAL HEAD AND NEW POLY ALTRX LINER. DOI : (B)(6) 2021 DOR : (B)(6) 2021 LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 13235853 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT COMPLAINED OF PAIN IN HER HIP. HE BELIEVED THE CUP MAY BE LOOSE, AND WANTED TO REMOVE IT AND REPLACE WITH A REVISION CUP. AFTER REMOVING THE LINER AND SCREWS HE INSPECTED THE CUP AND FOUND THAT THE CUP WAS NOT LOOSE. HE IMPLANTED NEW SCREWS, HEAD AND A CONSTRAINED LINER. HE WAS UNABLE TO GET THE LOCKING RING TO SEAT ON THE CONSTRAINED LINER DUE TO VISUALIZATION AND DECIDED TO REMOVE IT. HE REPLACED IT WITH A NEW +4, 10 DEGREE LINER AND APPROPRIATE SIZE HEAD. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12820648 ↗
• InjuryAug 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMAX LINER WAS FRACTURED DURING IMPLANTATION WITH KINCISE IMPACTOR. DECISION WAS MADE TO IMPLANT NEW CUP/HOLE ELIMINATOR/CERAMAX LINER. EXPLANTS ARE BEING RETURNED. IT WAS ALSO INDICATED THAT THERE WAS A SURGICAL DELAY OF 15 MINUTES. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387819 ↗
• InjuryJul 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT REASON FOR REVISION WAS CERAMAX LINER FRACTURE. SURGERY DONE APPROX. 1 YEAR AGO. THERE WAS NO UNUSUAL/TRAUMATIC EVENT THAT LED TO THE PROTHESIS FAILURE. THE PATIENT WAS SIMPLY WALKING WHEN THE EVENT HAPPENED. THE CERAMAC LINER HAD A FULL/COMPLETE FRACTURE. THE SURGEON VERIFIED INTEROP THAT IMPLANT POSITION LOOKED ADEQUATE, AND COULDN'T IDENTIFY ANY POTENTIAL PROBLEMS THAT COULD HAVE LED TO THE IMPLANT FAILURE. SURGICAL DELAY OF 1 HOUR. DOI: (B)(6) 2020. DOR: (B)(6) 2021; UNKNOWN AFFECTED SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12210965 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN IN THIGH SO THE DOCTOR REVISES STEM AND CUP. DOI: (B)(6) 2015 - DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Pain

  MAUDE report 12163790 ↗
• InjuryFeb 3, 2021Fracture; Fracture

  THE SURGEON PERFORMED TOTAL HIP ARTHROPLASTY USING DEPUY SUMMIT STEM, DEPUY PINNACLE SECTOR GRIPTION SHELL, DEPUY 36MM +1.5MM CERAMIC FEMORAL HEAD AND DEPUY PINNACLE 36/52 CERAMIC LINER ON THE PATIENT IN LATE 2019. IN MAY OF 2020, THE PATIENT COMPLAINED TO THE SURGEON OF A SQUEAKY HIP FOLLOWING PARTICIPATING IN A BASEBALL GAME. IN AUTUMN OF 2020, PATIENT COMPLAINED TO THE SURGEON OF HIP PAIN, AND FOLLOWING X-RAYS AND OTHER ASSESSMENTS, SURGEON DETERMINED THAT THE PATIENT¿S CERAMIC LINER HAD FRACTURED. PATIENT WAS BOOKED FOR REVISION SURGERY. SURGEON PERFORMED REVISION SURGERY TO REMOVE A FRACTURED 36/52 CERAMIC LINER (121887652) FROM A 52 SECTOR GRIPTION SHELL (121732052). THE HIP JOINT WAS DISLOCATED, THE CERAMIC LINER WAS ASSESSED AND CONFIRMED TO BE FRACTURED, ALL THE PIECES OF THE LINER WERE REMOVED FROM THE SHELL AND THE SURROUNDING WOUND. THE WOUND WAS THEN THOROUGHLY IRRIGATED AND THEN SURGEON DECIDED TO REMOVE THE SHELL OUT OF AN ABUNDANCE OF CAUTION. SHELL WAS REMOVED SUCCESSFULLY. SURGEON THEN PROCEEDED TO REAM THE ACETABULUM UP TO 56MM AND THEN IMPLANTED A 56MM PINNACLE SECTOR GRIPTION SHELL, AND AFTER PERFORMING TRIAL REDUCTION, FOLLOWED BY IMPLANTING A 36/56 PINNACLE C

  Patient problems: Pain

  MAUDE report 11273292 ↗
• MalfunctionJan 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHEN IMPACTING THE CERAMIC LINER, THE CERAMIC LINER BROKE. THE BROKEN LINER WAS REMOVED AND ANOTHER ONE WAS USED TO COMPLETE CASE. IT WAS UNKNOWN WHY THE LINER BROKE. NO FURTHER INFO IN KNOWN AT THIS TIME. THE LINER WILL BE RETURN TO BE INSPECTED. SURGICAL DELAY OF 5 MINS.

  Patient problems: Insufficient Information

  MAUDE report 11148488 ↗
• InjuryJul 13, 2020Fracture; Noise, Audible; Fracture; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT PATHOGENIC SQUEAKING WITH INCREASING DISCOMFORT IN HIS HIP. CERAMIC INSERT FRACTURED UPON EXTRACTION. AFTER COPIOUS IRRIGATION AND VISUAL INSPECTION, SURGEON CHOOSES TO COMPLETE THE LINER AND HEAD EXCHANGE. DOI: (B)(6) 2016. DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Discomfort; No Code Available

  MAUDE report 10264645 ↗
• MalfunctionJan 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON PLACED CERAMIC LINER IMPLANT INTO CUP, INDICATED IT WAS LINED UP CORRECTLY AND FLUSH BEFORE IMPACTING. SURGEON LIGHTLY IMPACTED LINER WITH MALLET AND STRAIGHT HANDLE IMPACTOR. CERAMIC LINER CRACKED AND SPLIT ON FIRST IMPACT. SPENT 15-20 MINUTES REMOVING LINER AND FRAGMENTS. DOE: (B)(6) 2019, LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 9577779 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Naturally Worn; Noise, Audible; Device Dislodged or Dislocated; Naturally Worn; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR JOINT EFFUSION EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2015, DOE: (B)(6) 2016, (RIGHT HIP).

  Patient problems: Joint Dislocation; Muscular Rigidity; No Code Available; Pain; Tissue Damage

  MAUDE report 8662643 ↗
• MalfunctionMay 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER WAS FRACTURED UPON IMPACTION. DOE: (B)(6) 2019, RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 8587978 ↗
• InjuryJan 15, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC INSERT CRACKED DURING SURGERY. THE SURGEON GOT THE INSERT STUCK AND ATTEMPTED TO HIT IT TO CHANGE THE POSITION AND IT CRACKED ON THE RIM. SURGICAL DELAY IS 10 MINS.

  Patient problems: No Code Available

  MAUDE report 8249567 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR AFTER FIRST REVISION.

  Patient problems: Tissue Damage

  MAUDE report 7996659 ↗
• MalfunctionOct 12, 2018Fracture; Fracture

  CERAMAX INSERT FRACTURED AT TIME OF IMPACTION INTO ACETABULAR SHELL. FRACTURED INSERT AND PARTICLES HAD TO BE RETRIEVED FROM PATIENT.

  Patient problems: Not Applicable

  MAUDE report 7962579 ↗
• InjuryOct 2, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT FELL AND HAD HIP PAIN AFTERWARDS.

  Patient problems: No Code Available; Pain

  MAUDE report 7925372 ↗
• InjurySep 26, 2018Break; Break

  THE RIM OF THE CERAMAX CERAMIC INSERT 36 X 52 SHATTERED AFTER THE THIRD MALLET BLOW WITH THE 36 MM CUP IMPACTOR. THE CERAMIC INSERT WAS PLACED SQUARELY INTO THE ACETABULAR CUP WITH THE SUCTION CUP TECHNIQUE PRIOR TO IMPACTION. BROKEN INSERT WAS REMOVED, THE AREA LAVAGED, AND A NEW POLYETHYLENE INSERT WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 7911952 ↗
• InjuryAug 13, 2018Break; Break

  THE PATIENT WAS REVISED TO REMOVE BROKEN CERAMIC LINER.

  Patient problems: No Code Available

  MAUDE report 7776420 ↗
• MalfunctionAug 13, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENTS CERAMIC LINER BROKE. SURGEON DID DEBRIDEMENT AND PUT A NEW LINER AND FEMORAL HEAD. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7776325 ↗