CERAMAXRecalls & reported problems across all models
Depuy (Ireland) · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 8 models of CERAMAX by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2017 and May 29, 2026 — classified as 48 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Fracture” (61 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CERAMAX problems
Device problems
- Fracture61
- Adverse Event Without Identified Device or Use Problem10
- Device Dislodged or Dislocated8
- Break3
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information2
- Noise, Audible2
- Difficult to Insert1
Patient problems
- No Code Available18
- Insufficient Information15
- Pain13
- Not Applicable11
- No Clinical Signs, Symptoms or Conditions10
- Joint Dislocation9
- No Consequences Or Impact To Patient8
- Unspecified Infection6
CERAMAX models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CERAMAX 1218-87-652Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented30 reports
- CERAMAX 1218-87-654Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented19 reports
- CERAMAX 1218-87-656Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented14 reports
- CERAMAX 1218-87-658Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented9 reports
- CERAMAX 1218-89-648Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented6 reports
- CERAMAX 1218-87-660Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented5 reports
- CERAMAX 1218-87-662Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
- CERAMAX 1218-89-660Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 report
Recent CERAMAX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT CERAMAX LINER WAS IMPLANTED AND SHATTERED UPON IMPACTION. DOE: (B)(6) 2026. FOLLOW UP WITH REPORTER: A. AFFECTED SIDE WAS THE LEFT SIDE. B. YES, IT SHATTERED INTO NUMEROUS PIECES. ALL FRAGMENTS WERE COLLECTED AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334496 ↗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 ↗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 ↗MalfunctionMar 4, 2026Fracture
IT WAS REPORTED THAT THE PATIENT WAS HAVING A RIGHT TOTAL HIP. DURING IMPACTION OF THE CERAMIC LINER, A PIECE OF THE LINER FRACTURED OFF. THE SURGEON HAD TO REMOVE THE LINER AND IMPLANT A NEW ONE. THE BROKEN PIECES OF THE FRACTURED LINER WAS RETRIEVED. AFFECTED SIDE: RIGHT HIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506414 ↗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 ↗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 ↗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 ↗MalfunctionJun 11, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, THE CERAMAX CERAMIC INSERT BROKE INTO MULTIPLE PIECES WHEN IMPACTED INTO THE ACETABULAR SHELL. THE SURGEON WAS UNABLE TO USE THE LINER, AND IMPLANTED A POLY LINER IN PLACE OF THE BROKEN CERAMIC LINER. AFFECTED SIDE: RIGHT HIP.
Patient problems: Insufficient Information
MAUDE report 22182840 ↗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 ↗InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. THE SURGEON DID A WASHOUT WITH LINER AND HEAD EXCHANGE. THE HOSPITAL RETAINED THE COMPONENTS FOR THE PATIENT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Infection
MAUDE report 19656963 ↗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 ↗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 ↗InjuryOct 5, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH A FRACTURED CERAMAX LINER. IT WAS CONFIRMED INTRAOPERATIVELY. THE CERAMIC PIECES OF THE LINER APPEARED TO BE MOSTLY FROM THE EQUATOR PORTION OF THE LINER WERE RETRIEVED FROM SOFT TISSUE. THE MAJORITY OF THE LINER WAS STILL IN ONE PIECE AND WAS EXTRACTED WITH THE SUCTION CUP PROVIDED IN THE CERAMAX INSTRUMENTATION. THE WOUND WAS THOROUGHLY DEBRIDED. A PINNACLE ALTRX LINER ALONG WITH A NEW BIOLOX TS CERAMIC HEAD WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.
Patient problems: Unspecified Tissue Injury
MAUDE report 17876856 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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