CERAMAX 1218-87-654Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295012528), received between Aug 23, 2017 and Mar 6, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER WAS IMPACTED INTO ACETABULAR SHELL, CRACKED INSIDE THE SHELL. A FEW FRAGMENTS WERE REMOVED. DOCTOR REPORTED THE LINER WAS STILL WELL SEATED AND LEFT IT IN PLACE. DOE: (B)(6) 2026. LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 24534639 ↗
• MalfunctionJul 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE CERAMIC LINER, THE SURGEON BROKE THE IMPLANT AND HAD TO RESORT TO ANOTHER TYPE OF LINER. THERE WAS A SURGICAL DELAY OF 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914388 ↗
• MalfunctionJun 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHEN IMPLANTING THE CERAMAX LINER THE DOCTOR NOTICED A SMALL CRACK AFTER HE IMPACTED INTO THE SHELL. HE REMOVED THE CRACKED CERAMAX LINER AND USED AN ALTRX LINER INSTEAD. DOE: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14734795 ↗
• MalfunctionMar 15, 2022Fracture; Fracture

  THE RIM OF THE CERAMIC LINER FRACTURED DURING INSERTION. LINER WAS REMOVED AND A NEW CERAMIC LINER WAS INSERTED. SURGICAL DELAY OF 10 MINUTES OCCURRED. NO ADVERSE AFFECTS ON THE PATIENT. DOE: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765915 ↗
• InjuryMay 17, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON SAID HE WAS UNSURE IF THE LINER WAS DISASSOCIATED INTRAOPERATIVELY OR BECAME DISASSOCIATED POSTOPERATIVELY. THE SURGEON SAID THE PATIENT WANTED HIS HIP REVISED BECAUSE OF PAIN AND LACK OF MOTION. THE SURGEON EXPLAINED A 54X36 CERAMAX LINER. THE SURGEON SAID THE LINER WAS FRACTURED. THE SURGEON TRIALED A 54X36 +4 10 DEGREE AND A 36 X+8.5 CERAMIC BIOLOGY TS CERAMIC HEAD AND THE SURGEON SAID HIP STABILITY AND LEG LENGTH WERE ACCEPTABLE. THE SURGEON ASKED THE NURSE TO OPEN THE SAME IMPLANTS MATCHING THE TRIALS THAT WERE USED. THE HOSPITAL TOOK POSSESSION OF ALL EXPLANTED ITEMS. THE SURGEON SAID THAT HE FEELS THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. DOI: (B)(6) 2016 DOR: (B)(6) 2021 AFFECTED SIDE: LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 11836536 ↗
• InjuryDec 16, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS EXPERIENCING PAIN THAT LED TO THE REVISION SURGERY. AFFECTED SIDE IF LEFT HIP.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11021022 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ILIOPSOAS BURSITIS OF LEFT (STUDY) HIP EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT HIP). TREATMENT: INJECTION INTO ILIOPSOAS BURSA. PRODUCT DETAILS: COMPONENT: SUMMIT STEM POROCOAT STD OFFSET SZ 6, CATALOG NUMBER: 157001120, LOT NUMBER ID: H33727. COMPONENT: CERAMAX CERAMIC INSERT NEUTRAL 54MM OD 36MM ID, CATALOG NUMBER: 121887654, LOT NUMBER ID: 849743. COMPONENT: PINNACLE SHELL SECTOR 54MM, CATALOG NUMBER: 121722054, LOT NUMBER ID: HC0470. COMPONENT: BIOLOX DELTA FEMORAL HEAD CERAMIC 36MM +8.5, CATALOG NUMBER: 136536330, LOT NUMBER ID: 8550546. COMPONENT: CANCELLOUS BONE SCREW 35MM, CATALOG NUMBER: 121735500, LOT NUMBER ID: D16091490.

  Patient problems: Pain; Skin Irritation

  MAUDE report 9451203 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND, OPEN, BUTTOCK WITH COMPLICATION, LEFT, SEQUELA EVENT IS SERIOUS AND IS CONSIDERED MODERATE - POORLY TOLERATED, SUSTAINED AND INTERFERES WITH NORMAL ACTIVITY AND REQUIRES MEDICAL ATTENTION. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2017. (LEFT HIP).

  Patient problems: Abscess; Hematoma; Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9424698 ↗
• InjuryOct 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORD RECEIVED. PPF ALLEGES DISLOCATION AND INFECTION. DOI: (B)(6) 2007, (STEM AND CUP). DOI: (B)(6) 2015, (HEAD AND LINER). DOR: (B)(6) 2016, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 9191981 ↗
• InjuryOct 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORD RECEIVED. PPF ALLEGES OPEN AND CLOSED DISLOCATION AND INFECTION AFTER THE FIRST REVISION. DOI: (B)(6) 2007 (STEM AND CUP); DOI: (B)(6) 2014 (HEAD AND LINER); DOR: NONE REPORTED; RIGHT HP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 9191466 ↗
• MalfunctionMar 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS INSTALLING A CERAMAX LINER USING INSTEROR HANDLE AS SURGEON IMPACTED THE LINER CHIPPED ON RIM. SURGICAL DELAY OF 10 MINUTES.

  Patient problems: No Code Available

  MAUDE report 8428542 ↗
• MalfunctionJan 23, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS REPLACING THIS PATIENT¿S RIGHT HIP WITH THE PLAN TO USE CERAMIC PINNACLE LINER. WHEN THE SURGEON WENT TO SEAT THE LINER, WHICH WAS IN A CORRECT POSITION, THE LINER CRACKED INTO MULTIPLE PIECES. THE LINER AND IT¿S DEBRIS WERE REMOVED ALONG WITH THE CUP.

  Patient problems: Not Applicable

  MAUDE report 8270169 ↗
• InjuryJan 15, 2019Fracture; Fracture

  THE PATIENT WAS REVISED DUE TO BROKEN CERAMIC LINER. FEMORAL HEAD, CERAMIC LINER AND STEM WERE REPLACED.

  Patient problems: No Code Available

  MAUDE report 8249896 ↗
• InjuryOct 30, 2018Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS THE BROKEN LINER.

  Patient problems: No Code Available

  MAUDE report 8019020 ↗
• MalfunctionMay 9, 2018Fracture; Fracture

  DER STATES CERAMIC LINER BROKE WHEN IMPACTED DURING SURGERY. DOE: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7498555 ↗
• MalfunctionApr 26, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER BROKE WHEN IMPACTED DURING SURGERY. DOE: (B)(6) 2018; LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7463867 ↗
• InjuryDec 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE LINER ASSOCIATED WITH THIS EVENT WAS NOT REVISED. DOI: (B)(6) 2017; DOR: (B)(6) 2017 LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7118432 ↗
• InjuryAug 30, 2017Fracture; Fracture

  PATIENT WAS REVISED DUE TO FRACTURE OF THE CERAMIC LINER.

  Patient problems: No Information

  MAUDE report 6831960 ↗
• MalfunctionAug 23, 2017Fracture; Fracture

  DER STATES THAT THE CERAMIC LINER WOULDN'T SIT PROPERLY IN THE SIZE 54 CUP, SURGEON TRIAL SEVERAL TIMES TO REPOSITION IT AND SEAT IT BUT THE LINER WOULDN'T SEAT. A 22 LINER WAS TRIED AND THE RIM OF THE LINER CHIPPED OFF UPON IMPACTION. THE SURGEON FEELS THERE IS AN ISSUE WITH THE CUP THAT WOULDN'T ALLOW LINER TO SEAT.

  Patient problems: No Information

  MAUDE report 6813421 ↗