BIOLOX DELTA 1365-36-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295033592), received between Oct 3, 2017 and Aug 31, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Fracture

  It was reported that patient presented with a Fractured 11/13 srom ceramic head. The patient had an srom stem and sleeve with pinnacle cup sz. 52 and pinnacle +4 10 degree 36mm ID Liner and Srom 11/13 Ceramic 36mm head. The surgeon performed an extensive debridement and replaced the Liner (matching what was removed) and a ceramic head. There was concern that using a metal head would be worse than the harder ceramic bearing when considering 3rd body wear from residual ceramic.DOI: (b)(6) 2016,DOR: (b)(6) 2026,Affected side: Right.

  Patient problems: Insufficient Information

  MAUDE report 50524520 ↗
• InjuryFeb 13, 2025Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - THERE WAS NO DELAY.

  Patient problems: Fall

  MAUDE report 21374765 ↗
• InjuryDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO FURTHER CONSEQUENCES.

  Patient problems: Joint Dislocation

  MAUDE report 18373689 ↗
• InjuryOct 27, 2023Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT IT WAS A POLY EXCHANGE FOR INFECTED KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18021350 ↗
• InjuryAug 21, 2023Fracture; Fracture

  PATIENT WAS REVISED DUE TO A BROKEN CERAMTEC 36MM 11/13 PLUS 9 CERAMIC HIP BALL . EXPLANT WAS SUCCESSFUL. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 17583940 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THA PERFORMED YEARS AGO, ORIGINAL DATE UNKNOWN. REVISION COMPLETED DUE TO DISLOCATION. PATIENT WAS IMPLANTED WITH A CONSTRAINED LINER AND LONGER LENGTH ON THE HIP BALL. PATIENT RETURNED TO SURGEON WITH SUSPECTED INFECTION IN THE HIP. INFECTION WAS CONFIRMED AND SURGEON PERFORMED A THOROUGH WASHOUT OF THE JOINT AND CHANGED THE CONSTRAINED LINER AND FEMORAL HEAD. ORIGINAL IMPLANTS WERE IMPLANTED AFTER THE WASHOUT. SURGEON REDUCED THE HIP AND FOUND IT TO BE STABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13250666 ↗
• InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS HIP DISLOCATED TWICE. THE SURGEON DECIDED TO IMPLANT A CONSTRAINED LINER. 64+4 10 DEGREE AND A 40+9 H. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 12392433 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LEG LENGTH AND OFFSET DISCREPANCY. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: Physical Asymmetry

  MAUDE report 10984976 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INFECTION. ALL IMPLANTS REMOVED EXCEPT FOR THE PROXIMAL SLEEVE. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10677826 ↗
• InjuryMar 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THERE WERE REVISION DUE TO CERAMIC HEAD BROKEN. DOI: UNKNOWN; DOR: (B)(6) 2020; AFFECTED SITE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9814061 ↗
• InjuryMay 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES PULMONARY EMBOLISM, LOOSE CUP, ELEVATED METAL IONS AND DISLOCATION WITH CLOSED REDUCTION. CUP AND STEM WERE ALREADY CAPTURED ON (B)(4) SINCE PPF INDICATED THAT THEY WERE NOT REVISED DURING 1ST REVISION. DOI: (B)(6) 2014; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available; Pulmonary Embolism

  MAUDE report 8611763 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PULMONARY EMBOLISM. LEFT HIP.

  Patient problems: Pulmonary Embolism

  MAUDE report 8539801 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INITIAL HIP DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY, IT IS RELATED TO PROCEDURE. DOI: (B)(6) 2018. DOE: (B)(6) 2019. (LEFT HIP). TREATED VIA CLOSED REDUCTION. 136536240 8642059 HEAD; 122136458 J0018T LINER; 550536, 8657788 S-ROM SLEEVE; 563620, 8934901 S-ROM STEM; 121701058 8659264 CUP; 124603000 D18091938 HOLE ELIMINATOR.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 8478922 ↗
• InjuryNov 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2016 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8101303 ↗
• InjuryOct 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID A WASHED OUT AND EXCHANGE THE HEAD AND LINER.

  Patient problems: Unspecified Infection

  MAUDE report 6910547 ↗