BIOLOX DELTA 1365-36-740Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10603295033684), received between Jun 22, 2017 and Jul 27, 2026 — classified as 93 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (44 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 7, 2014Class IITerminated

   Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the

   Z-0825-2015 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the head liner was explanted due to infection. No delays in case or harm to the patient. There were no complaints from the surgeon.DOI: (b)(6)2026.DOR: (b)(6)2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50036290 ↗
• InjuryJul 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT REVISED DUE TO DISASSOCIATION OF LINER FROM ACETABULAR SHELL WITH DISLOCATION. HEAD WAS CHANGED AS WELL TO AIDE IN REVISION OF SHELL. ACETABULAR LINER WAS LOOSE AND LOOSENING INTERFACE AT BONE TO IMPLANT INTERFACE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25736982 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25540778 ↗
• InjuryApr 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION OF W SMALL HEADBALL. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24756617 ↗
• 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 23497116 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT HAD AN ONGOING GROIN PAIN AND DISCOMFORT FOLLOWING BOTH PRIMARY PROCEDURE AND FIRST REVISION.

  Patient problems: Discomfort; Pain; Unspecified Tissue Injury

  MAUDE report 22912195 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HEAD AND LINER EXCHANGE. THE CUP AND LINER WERE A COMPETITORS PRODUCT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22543339 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22542440 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED JOINT SPACE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22493548 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH I&D DUE TO INFECTION. HEAD AND LINER (COMPETITOR) WERE EXCHANGED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22356818 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21710871 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21337606 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED CUP FOR INSTABILITY FOLLOWING LUMBAR/PELVIS FUSION. THERE WAS NO IMPLANT FAILURE AND NO BROKEN PIECES. THERE WAS NO LOOSENING AND NO CASE DELAY. THERE WAS NO SURGEON CONCERNS. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21297512 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP WASH OUT WITH HEAD AND LINER EXCHANGE DUE TO INFECTED HIP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21137329 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WERE NO DELAYS IN SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19712114 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTED TOTAL HIP WAS WASHED OUT. THE PROXIMAL BODY FOR THE RECLAIM STEM WAS ATTEMPTED TO BE REMOVED. THE DISASSEMBLY TOOL WAS INSERTED INTO PROXIMAL BODY TO DISENGAGE IT, BUT THE TEETH ON THE COLLET PORTION SHEARED OFF WHILE TRYING TO SEPARATE BODY FROM STEM. THIS WAS ATTEMPTED WITH TWO DIFFERENT DISASSEMBLY TOOLS, AND THE TEETH SHEARED OFF BOTH COLLET PORTIONS OF THE DISASSEMBLY TOOLS. THE BODY WAS NOT ABLE TO BE DISENGAGED. THE CONSTRAINED LINER AND HEAD WERE EXCHANGED DURING THE WASHOUT PORTION OF THIS PROCEDURE. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19647768 ↗
• InjuryJan 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18580455 ↗
• InjuryDec 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18300214 ↗
• InjuryJun 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR ACUTE INFECTION. AFTER THAT SURGEON CHOOSE TO UPSIZED FROM A 36+8.5 CERAMIC TS HEAD TO A+12. SURGEON EXPRESSED CONCERN THAT THE BALL APPEARED TO BE SETTING VERY HIGH ON THE FEMUR WHEN HANDED POST OP FILMS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17224080 ↗
• InjuryJun 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS PREVIOUSLY REVISED DUE TO DISLOCATION. THE PATIENT STARTED DISLOCATING AGAIN, WHICH THE SURGEON ATTRIBUTES TO SOME SOFT TISSUE/ABDUCTOR DEFICIENCIES. REMOVED HEAD AND LINER AND INSERTED A CONSTRAINED LINER, WITH NEW TITANIUM SLEEVE HEAD. PATIENT WAS STABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17152734 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE INLAY AND CERAMIC HEAD CHANGEMENT DUE TO INFECTION DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN, (B)(4), DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE, (B)(4), DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 16277355 ↗
• InjuryNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PC WAS CREATED TO CAPTURE THE EVENT: ON (B)(6) 2012 THE PATIENT HAD LEFT MOM HIP REVISED, A +12 DELTA CERAMIC FEMORAL HEAD WAS PLACED DURING THIS PROCEDURE ALONG WITH COMPETITOR CUP, SCREWS, AND POLYLINER. IT MAY BE ASSUMED THAT THE DELTA CERAMIC FEMORAL HEAD WAS DEPUYS. ON (B)(6) 2014 THE PATIENT HAD LEFT HIP REVISION WITH CAGE/CUP CONSTRUCT TO ADDRESS THE PREOPERATIVE DIAGNOSIS OF ASEPTIC LOOSENING OF LEFT ACETABULAR COMPONENT (COMPETITOR COMPONENT). THE INDICATIONS FOR SURGERY INCLUDED: INCREASING PAIN AND ¿SCREWS WERE BROKEN¿. THE PATIENT HAS ALSO HAD DISLOCATIONS, WHICH WERE NOTED TO BE ¿CONSISTENT WITH MIGRATION OF THE CUP¿. DURING THE SURGERY, THE SURGEON OBSERVED COMPETITOR SCREW WAS BROKEN. THE FEMORAL HEAD WAS REVISED ALONG WITH THE CUP/LINER/SCREWS. A +12 REVISION CERAMIC HEAD WAS PLACED. (NEW PC NEEDS TO BE CREATED). DOI: (B)(6) 2012 (HEAD), DOR: (B)(6) 2014 (HEAD), LEFT HIP 3RD REVISION.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 15800905 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP DONE AT A DIFFERENT HOSPITAL AT AN UNKNOWN DATE. THE COMPONENTS USED WERE A CEMENTED SUMMIT STEM, PINNACLE CUP AND NEUTRAL LINER WITH A 36 +12 FEMORAL HEAD. THIS PATIENT WAS BEING REVISED BECAUSE THE CEMENT MANTLE AROUND THE STEM HAD FRACTURED AND APPEARED TO HAVE SUBSIDED LEAVING THE PATIENT APPROXIMATELY 1 CM SHORT ON THIS SIDE. THE STEM WAS REMOVED AND THE CEMENT MANTLE WAS REMOVED. A RECLAIM 21X140 STEM WITH A 24X85 PROXIMAL BODY WAS USED ALONG WITH A 36 +1.5 CERAMIC HEAD. THE NEUTRAL LINER WAS ALSO REMOVED AND REPLACED WITH A 54X36 +4 10 DEGREE LINER. LOOSENING INTERFACE WAS BONE TO CEMENT AND CEMENT TO IMPLANT. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 15485013 ↗
• InjuryMay 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PFS, PPF, AND MEDICAL RECORD RECEIVED. PPF ALLEGES THAT AFTER THE FIRST REVISION, PATIENT HAD DISLOCATION WITH OPEN REDUCTION AND FRACTURE FEMUR. PATIENT CURRENTLY USE WALKER AND CAN ONLY PUT 50% OF WEIGHT ON LEGS, HAD NUMBNESS, PAIN, LIMITED MOVEMENT, AND DIFFICULTY WALKING. PATIENT FELL IN (B)(6) 2021 AND HAD FRACTURED FEMUR DUE TO DIFFICULTY IN WALKING, AND PAIN. NERVE PAIN IS MUCH WORSE AT NIGHT WHEN LAY DOWN. DOI: (B)(6) 2019; DOR: UNKNOWN ; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Dislocation; Loss of Range of Motion; Numbness; Pain

  MAUDE report 14349292 ↗
• InjuryOct 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED BACK ON (B)(6) 2021. PATIENT WAS DISLOCATING AND NEEDED A LONGER FEMORAL HEAD. THE ACETABULAR COMPONENT WAS A STRYKER CUP. THE CASE # FOR THAT REVISION IS (B)(4). UNFORTUNATELY THE PATIENT IS STILL DISLOCATING. SURGEON FELT IT WOULD BE BEST TO CONVERT THE STRYKER LINER TO A CONSTRAINED LINER. THE 36MM +12 DEPUY HEAD WAS REMOVED AND A 28MM +12 FEMORAL HEAD WAS IMPLANTED. THE HIP WAS REDUCED INTO THE CONSTRAINED LINER AND FELT TO BE STABLE. CLOSING PROCESS BEGAN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12704157 ↗