CERAMAX 1218-87-656Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295012535), received between Aug 2, 2017 and May 23, 2024 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT UPON IMPACTING CERAMIC LINER IT WAS NOTED THAT THE LINER WAS CRACKED/BROKEN ON UPPER LIP OF LINER. THERE WAS LOOSENING AT AN UNKNOWN INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. THERE WAS SURGICAL DELAY. DOE: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19380473 ↗
• MalfunctionApr 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT SURGEON LAYED THE 56 CERAMIC LINER INTO THE CUP AND FELT IT WAS EVEN AROUND THE CUP EDGE. SURGEON LIGHTLY TAPPED THE LINER WITH THE 36 MM IMPACTOR AND A PIECE BROKE OFF THE RIM ON THE CUP SIDE. THE LINER WAS REMOVED, MAKING SURE ALL PIECES WERE ACCOUNTED FOR BEFORE INSERTING A NEW LINER. THERE WAS A 9 MINUTE DELAY BEFORE ANOTHER LINER COULD BE DELIVERED TO THE HOSPITAL. DOE: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP

  Patient problems: Insufficient Information

  MAUDE report 19201590 ↗
• InjuryDec 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATED RIGHT HIP. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9495439 ↗
• InjuryAug 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING A CERAMAX 36 X 56 MM NEUTRAL LINER IN A PRIMARY TOTAL HIP AND IMPACTED IT IN CROOKED. IN ATTEMPTING TO LOOSEN AND REMOVE THE LINER, THE EDGE OF THE PRODUCT CRACKED. A COUPLE PIECES OF THE LINER WERE REMOVED AND THEN THE FULL LINER CAME LOOSE AND WAS REMOVED. THE SURGEON THEN IMPLANTED A NEW CERAMAX LINER OF THE SAME SIZE CORRECTLY AND FINISHED THE CASE. WE HAD TO WAIT 50 MINUTES FOR A NEW LINER TO ARRIVE DURING THE PROCESS. DOE: (B)(6) 2019; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 8910599 ↗
• MalfunctionJul 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PRIMARY THA PERFORMED TODAY WHEN CERAMIC LINER FRACTURED INTRAOPERATIVELY DURING FINAL SEATING OF LINER. SURGEON STATED, "THIS MUST BE A DEFECTIVE PRODUCT, I HAD IT LINED UP PERFECTLY." ALL PIECES WERE REMOVED, THE CUP AND SCREW WERE EXAMINED AND DETERMINED TO BE "GOOD". ANOTHER CERAMIC LINER OF THE SAME SIZE WAS OPENED AND IMPLANTED WITHOUT ISSUE. NO FURTHER PATIENT INFORMATION AVAILABLE. DOE: (B)(6) 2019, LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 8759628 ↗
• MalfunctionJun 27, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE CERAMIC LINER WAS BEING INSERTED AND THE LINER CRACKED AROUND THE EDGE. I BELIEVE THE LINER WAS NOT SEATED CORRECTLY AND WHEN IMPACTED THE EDGE CAUGHT ON CUP AND FRACTURED. ALL PIECES WERE RECOVERED AND WILL BE RETURNED. DOE: (B)(6) 2019, LEFT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739500 ↗
• InjuryJun 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT CERAMIC ON CERAMIC TOTAL HIP WAS DONE (B)(6). PATIENT DOING FINE UNTIL ABOUT A WEEK AGO; WHILE SWIMMING IN THE POOL HE SAID HE FELT A "POP" IN HIS HIP. WENT INTO OFFICE AND THEY DISCOVERED THAT THE CERAMIC LINER WAS SHATTERED. REMOVED HEAD AND LINER; CLEANED OUT AND IMPLANTED A TS CERAMIC HEAD AND ALTRX POLY LINER. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8674441 ↗
• MalfunctionFeb 4, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WASN¿T SURE WHAT HAPPENED BUT FELT HE IMPACTED THE CERAMIC LINER PROPERLY AND IT ENDED UP SHATTERING INTO FOUR (4) LARGER PIECES; THE PIECES WERE RETRIEVED FROM PATIENT AND PUT IN A POLY LINER INSTEAD. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8302665 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ACETABULAR COMPONENT LOOSENING, FAILURE TO INGROW. EVENT IS SERIOUS. EVENT IS RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2016; DOE: (B)(6) 2018; DOR: (B)(6) 2018; (LEFT HIP).

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7726402 ↗
• InjuryJul 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A HIP REVISION WAS PERFORMED BECAUSE PATIENT DISLOCATED A COUPLE TIMES. CERAMIC LINER WAS EXPLANTED AND REPLACED WITH A 36 +4/10 LINER. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7718669 ↗
• MalfunctionMay 21, 2018Fracture; Fracture

  DER STATES THAT DURING A ROUTINE LEFT THA REPLACEMENT, A 56MM PINNACLE CUP WAS IMPLANTED. NO SCREWS WERE PLACED IN THE CUP. A CERAMAX 36X56 LINER WAS INSERTED AFTER FIXATION OF THE PINNACLE CUP. THE SURGEON CHECKED TO MAKE SURE THE LINER WAS PROPERLY INSERTED PRIOR TO IMPACTION. UPON IMPACTION THE LINER FRACTURED IN SEVERAL PLACES. THE BROKEN LINER WAS REMOVED, AND A NEW 36X56 CERAMAX LINER WAS INSERTED. THE 2ND LINER WAS IMPACTED AND SEATED CORRECTLY. PLEASE CHECK RETURNED FRACTURED LINER TO MAKE SURE IT IS WITHIN PROPER SPECIFICATIONS. DOE: (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7530526 ↗
• InjuryApr 10, 2018Fracture; Fracture

  DER STATES CERAMIC LINER WAS NOT SEATED WHEN IMPACTED AND FRACTURED. USED NEW LINER.

  Patient problems: Not Applicable

  MAUDE report 7411284 ↗
• InjurySep 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6851552 ↗
• InjuryAug 2, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATED THAT THE PATIENT DISLOCATED AS A RESULT OF A FALL. HE HAS CONTINUED TO DISLOCATE. THE SURGEON ELECTED TO REVISE THE CUP POSITION AND USE A POLY LINER ACCOMODATING A 40MM HEAD. REVISION SURGERY ACHIEVED A GOOD RESULT.

  Patient problems: Joint Dislocation; No Consequences Or Impact To Patient

  MAUDE report 6760690 ↗