BIOLOX DELTA 1365-36-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295033578), received between Nov 30, 2017 and Dec 18, 2025 — classified as 51 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 51 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY/DISLOCATION. NO OTHER INFORMATION IS KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 23838233 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20699676 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS WERE FULLY REMOVED DUE TO INFECTION. SURGEON PUT IN AN ANTIBIOTIC SPACER TO ALLOW THE INFECTION TO HEAL AND THE SITE WAS CLEANED THOROUGHLY BEFORE PUTTING IN THE ANTIBIOTIC SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18493388 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A LEFT HIP REVISION DUE TO DISLOCATED HIP. A NEW PINNACLE LINER AND SROM CERAMIC HEAD WERE IMPLANTED AT THAT TIME. THE PATIENTS PREVIOUS SURGERY WAS DONE IN BALTIMORE YEARS AGO. THE PATIENT IS NOW INFECTED AND CAME IN FOR RESECTION WITH PROSTALAC SPACER INSERTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18490215 ↗
• InjurySep 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED HIP TWICE. CHANGED POLY TO AN ELEVATED RIM AND THE HEAD FROM A +3 TO A +6. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17697948 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SROM STEM WAS TAKEN OUT, THE CUP LINER WAS REPLACED WITH SAME SIZE THAT WAS PUT IN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 17650656 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: REVISION (REVISED IMPLANTS NOT SPECIFIED).

  Patient problems: Joint Dislocation

  MAUDE report 17603879 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL NOTIFICATION UPDATE INDICATES A REVISION WAS COMPLETED ON 22 MAR 2024 TO ADDRESS INFECTION. THE STEM, HEAD, LINER, AND CUP WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 16817036 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS REPORTED THAT, PATIENT HAD A 52MM PINNACLE SECTOR CUP WITH A 36MM +4 10 DEGREE LINER, 36 +3 CERAMIC FEMORAL HEAD AND A 16X11 36 +6 S ROM STEM CURRENTLY IMPLANTED. SURGEON FELT THAT THE ACETABULAR CUP DID NOT HAVE PROPER VERSION. THE LINER, CUP AND FEMORAL HEAD WERE ALL EXPLANTED. SURGEON IMPLANTED A ZIMMER BIOMET CUP AND LINER THEN USED A METAL 36MM, 11/13 +9 FEMORAL HEAD. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15966056 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15615512 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY RIGHT TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2022. THE PATIENT PRESENTED BACK TO SURGEON FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT A REVISION PROCEDURE ON THEIR RIGHT HIP ON (B)(6) 2022 WHERE ONLY THEIR CERAMIC HEAD AND ALTRX LINER WERE REVISED. THE PATIENT'S PRIMARY CUP, STEM AND SLEEVE WERE LEFT IN SITU. DOI: (B)(6) 2022. DOR: (B)(6) 2022. RIGHT HIP. ADDITIONAL INFORMATION: REVISION WAS COMPLETED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15484005 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY LINER AND CERAMIC HEAD REVISED FOR INFECTION. SURGEON REMOVED EXISTING COMPONENTS AND IMPLANTED DUPLICATE REPLACEMENTS. HOSPITAL DISPOSED OF REMOVED IMPLANTS. 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 14845808 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE INSTABILITY DUE TO GREATER TROCHANTER FRACTURE. NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14136569 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DISLOCATION AFTER A FALL. SURGEON CHOSE TO REVISE SHELL TO COMPETITIVE ACETABULAR SHELL. FEMORAL HEAD WAS REMOVED FROM A SURGERY ON (B)(6) 2014. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 13860359 ↗
• InjuryFeb 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2016, DATE OF EVENT: (B)(6) 2022, (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Dislocation; Joint Laxity; Pain

  MAUDE report 13415782 ↗
• InjurySep 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A CORIN CUP AND AN SROM STEM IN FROM A FEBRUARY PRIMARY TOTAL HIP. HE HAS DISLOCATED MULTIPLE TIMES. THEY REVISED HIM TO A LATERALIZED LIPPED LINER AND CHANGED OUT FEMORAL HEAD TO ADD LENGTH. THE STEM REMAINED IN THE PATIENT. NOTHING WAS WRONG WITH ANY DEPUY PRODUCTS. DOI: (B)(6) 2021, DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 12555330 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT ALL IMPLANTS WERE LOOSE AND THERE WERE NO INSTRUMENTS THAT BROKE DURING THE CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12483207 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS REPORTED THAT PATIENT POST 1ST REVISION PATIENT STILL COMPLAINTS OF PAIN, ACHES, LIMITATIONS WITH ACTIVITY, HIGH COBALT AND CHROMIUM LEVELS CONTINUED UNTIL DEATH. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT PATENT SUFFERED POST OPERATIVE ACUTE BLOOD LOSS ANEMIA. DOI: (B)(6) 2005 (STEM,SLEEVE). DOI: (B)(6) 2013 (CUP,SCREWS,APEX,LINER,HEAD). DOR: NONE REPORTED. (LEFT HIP).

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Pain

  MAUDE report 12333826 ↗
• InjuryJul 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORD RECEIVED. ON (B)(6) 2021, THE PATIENT HAD A REVISION OF THE RIGHT TOTAL HIP TO ADDRESS HIP JOINT INSTABILITY AND DISLOCATION. THE PATIENT IS NOTED TO BE A POST REVISION (B)(6) 2016 FOR SEVERE METALLOSIS AND ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED EXTENSIVE EFFUSION. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE.

  Patient problems: Joint Dislocation; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12129561 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. MRI NOTES (B)(6) 2021 REVEAL MODERATE JOINT EFFUSION WITH SYNOVITIS AND MILD TENDINOSIS / SCARRING OF THE RIGHT GLUTEUS MINIMUS/MEDIUS. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL HIP REVISION DUE TO PAIN, IMPINGEMENT OF ILIOPSOAS TENDON AND DISRUPTION OF THE POSTERIOR CAPSULE REPAIR ¿ IT IS INDICATED 2 PREVIOUS ASPIRATIONS WERE PERFORMED BUT DID NOT INDICATE INFECTION. THE PATIENT¿S INFLAMMATORY MARKERS ARE ELEVATED. UPON ENTERING THE JOINT, IMPINGEMENT WAS IDENTIFIED. THE CUP WAS NOTED TO BE VERTICAL AND REPLACED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Muscle/Tendon Damage; Muscular Rigidity; Pain; Scar Tissue; Synovitis

  MAUDE report 11679424 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: (B)(6) 2017. DOR: (B)(6) 2021: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11507368 ↗
• InjuryFeb 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFFECTED SIDE OF THE PATIENT WAS RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11372010 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT HAD RECURRENT ISSUES WITH INFECTIONS AND DRAINING SINUS TRACTS IN HIP AREA OVER A NUMBER OF YEARS. A FIRST STAGE REVISION WAS PERFORMED LEAVING A SPACER IN SITU UNTIL THE SECOND STAGE OPERATION IS PERFORMED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11118084 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL HIP TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF REVISION: (B)(6) 2019, (RIGHT HIP). TREATMENT: REVISION OF CUP, 2 SCREWS, HOLE ELIMINATOR, LINER, STEM, PROXIMAL SLEEVE, AND HEAD--PLACEMENT OF ANTIBIOTIC SPACER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10837588 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SOFT TISSUE INFECTION WITH POSSIBLE DEEP INFECTION EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2020 (RIGHT HIP). TREATMENT: NONE (AWAITING SURGICAL I&D WITH POSSIBLE REVISION).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10559989 ↗