BIOLOX DELTA 1365-28-740Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295033332), received between Aug 31, 2017 and May 12, 2026 — classified as 38 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION, ORIGINALLY HAD A 46 CUP IN SO TOOK THE CUP OUT TO GO TO A 48 SO THEY COULD USE A CONSTRAINED LINER ON HER. THERE WAS NO OTHER INFORMATION AVAILABLE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25149264 ↗
• InjuryApr 17, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATION/FRACTURE DUE TO FALL. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 24913876 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24590607 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DONE ON 7/29/25 AND GOT AN INFECTION LATER ON. THE SURGEON DID A ZIMMER POLY AND DEPUY HEAD. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23019858 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED. AN ANTIBIOTIC SPACER WAS IMPLANTED BECAUSE OF INFECTION. ORIGINAL DATE OF SURGERY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23004260 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS I&D FOR SUSPECTED INFECTION. DOI: UNK. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22311495 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENT POST REVISION THA WITH A DISLOCATED HIP. AFTER APPROPRIATE EXPOSURE HAS TAKEN PLACE, THE HIP IS RELOCATED AND FOUND TO BE EXTREMELY STABLE, BEING ABLE TO BE BOTH INTERNALLY AND EXTERNALLY ROTATED TO EXTREME POSITIONS WITHOUT DISLOCATING. FROZEN SECTION DID SHOW 5 WHITE CELLS PER HIGH POWERED FIELD WHICH WAS SOMEWHAT CONCERNING. A THOROUGH I&D IS PERFORMED DUE TO THIS FINDING AND ELEVATED LABS AND RESORBABLE ANTIBIOTIC BEADS ARE PLACED. NEW COMPONENTS ARE PLACED WITH NO PATIENT HARM OR DELAY. AFFECTED SIDE: LEFT HIP

  Patient problems: Unspecified Infection

  MAUDE report 21060090 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIALLY HAD AN HPS 2 STEM WITH A STRYKER CUP. PATIENT WAS REVISED BACK ON (B)(6) 2024 DUE TO DISLOCATION. PATIENT HIP WAS SHOWING SIGNS OF INFECTION. SURGEON DID A HEAD/LINER EXCHANGE AND THOROUGHLY WASH OUT THE WOUND. SAME IMPLANTS WERE OPENED AND IMPLANTED THAT WERE REMOVED. THERE WAS NO SURGICAL DELAYS OR ADVERSE EVENTS. HIP WAS REDUCED AND STABILITY WAS CONFIRMED. DOI-(B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20881911 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH PUS DRAINAGE POSTOPERATIVELY FROM A REVISION THA. THE SURGEON PERFORMED AN EXTENSIVE I&D WITH EXCHANGE OF MODULAR COMPONENTS AND PLACEMENT OF ANTIBIOTIC RESORBABLE BEADS IN A DUAL SET UP. ALL COMPONENTS WERE WELL FIXED AND WELL FUNCTIONING. THERE WAS NO DELAY NOR PATIENT HARM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20746721 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD A RIGHT HIP REVISION TO ADDRESS RECURRENT DISLOCATION. PATIENT HAS A HISTORY OF METALLOSIS AND TISSUE DAMAGE PRIOR TO THE PATIENT¿S LAST REVISION. SINCE THE LAST REVISION THE PATIENT HAS DISLOCATED, FELT A LEG LENGTH DISCREPANCY, AND PAIN. DURING THE PROCEDURE THE SURGEON NOTED THAT THERE WAS AN ILIOTIBIAL BAND THAT WAS DISLOCATING ITSELF IN ADDITION TO THE HIP. THE STEM WAS WELL FIXED, THERE WAS SIGNIFICANT SOFT TISSUE DEFECT AT THE SITE OF THE INCISION. THE INSERT WAS NOTED TO BE DEFORMED DUE TO PREVIOUS DISLOCATIONS. ON (B)(6) 2019 THE PATIENT IS DISTANTLY OUT FROM HIS RIGHT HIP REVISION FOR INSTABILITY. HE HAD A FALL AND PAIN AFTER A FALL. NO ACUTE FRACTURE OR DISLOCATION. THE ASSESSMENT WAS THAT THE PATIENT HAD A PRETTY BAD CONTUSION, BUT HE DID NOT INJURE HIS HIP TO ANY SIGNIFICANT DEGREE. (B)(6), 2022 RIGHT HIP PAIN REPORTED. (B)(6) 2024 PATIENT PASSED AWAY. (NO SPECIFICS OR ALLEGATION OF PASSING BEING ATTRIBUTED DEPUY COMPONENTS OR PROCEDURE. DOI: (B)(6), 2019 DOR: (B)(6) 2019 RIGHT HIP DOE: (B)(6) 2019 THIS PC IS LINKED TO (B)(4) WHICH CAPTURES THE FIRST REVISION OF RIGHT HIP AND (B)(4) CAPTURES THE SECOND REVISION OF RI

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 20738040 ↗
• InjuryOct 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS A HPS 2 STEM AND A COMPETITOR CUP, AND DISLOCATED MULTIPLE TIMES RECENTLY ACCORDING TO THE SURGEON. THIS PATIENT WAS REVISED WHERE SURGEON EXPLANTED A 28MM + 12 TS CERAMIC HIP BALL AND COMPETITOR LINER, THE HPS 2 STEM WAS LEFT IN SITU. A NEW 28MM + 12 TS HIP BALL WAS IMPLANTED WITH A NEW COMPETITOR CONSTRAINED LINER. SURGEON DID NOT HAVE EXPLANATION WHY THE PATIENT DISLOCATED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20418255 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO HARM, NO BROKEN INSTRUMENT, NO DELAYS. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20078311 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. THE SURGEON REMOVED THE HEAD AND LINER AND INSERTED NEW. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19752611 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS NOT SATISFIED WITH THE STABILITY OF THE CONSTRUCT AFTER IMPLANTING A NEW HEAD WITH COMPETITORS DUAL MOBILITY. HE REMOVED THE HEAD AND CUP AND PUT IN A LARGER COMPETITOR'S CUP AND SWITCHED TO OUR 36 HEAD WITH A LONGER NECK LENGTH. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 18372977 ↗
• InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL AND DISLOCATED THE CONSTRAINED LINER. PATIENT WAS REVISED WITH THE SAME SIZE IMPLANTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18184223 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SWAPPED OUT IMPLANTS DUE TO AN INFECTION. A SAME SIZE IMPLANT WAS PUT BACK AFTER TAKING OUT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6)2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18063884 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18047968 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17952143 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D FOR POSSIBLE INFECTION. UNABLE TO DETERMINE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2029, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17556496 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. REMOVAL OF ALL IMPLANTS TOOK PLACE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16777460 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16239598 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D FOR CONFIRMED INFECTION WITH HEAD EXCHANGE. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16157570 ↗
• InjurySep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT HIP). TREATMENT: REVISION; ACETABULAR CONSTRAINING RING WAS REPLACED OVER THE CONSTRAINED LINER/OPEN REDUCTION.

  Patient problems: Hematoma; Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15360927 ↗
• InjuryJul 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. HEAD POLY EXCHANGE PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15093045 ↗
• InjuryMay 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID; 007-02564 STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. (LINER IS COMPETITOR). DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) /2022. (RIGHT HIP) REVISION OF DEPUY HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 14518421 ↗