BIOLOX DELTA 1365-32-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 10603295033462), received between Jan 4, 2018 and Sep 23, 2026 — classified as 97 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (51 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Dislodged or Dislocated

  It was reported that patient had dislocation.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50873784 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING DISCOMFORT AND IMPINGEMENT ISSUES, SO THE DOCTOR REVISED. NO KNOWN INFECTION PRESENT. NO DELAY IN SURGERY. DOI: (B)(6) 2017, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 25382290 ↗
• InjuryFeb 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH HEAD AND LINER EXCHANGE DUE TO DISLOCATION. DOI: UNKNOWN. DOR: (B)(6) 2026 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24472409 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION DUE TO IMPLANT. SWAPPING HEAD AND LINER. DOI- (B)(6) 2025. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24190649 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23802890 ↗
• InjuryOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025 . AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23424947 ↗
• InjuryMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED SOMETIME IN 2023 WHERE SHE RECEIVED A SUMMIT PINNACLE. AS A RESULT OF A FALL AND AN INJURY, THE PATIENT BEGAN TO HAVE DISLOCATION ISSUES OVER THE YEAR. DOCTOR DECIDED TO REVISE THE PATIENT¿S HIP, WHERE HE EXPLANTED THE ACETABULAR CUP, AND IMPLANTED ANOTHER CUP WITH A DUAL MOBILITY LINER TO STABILIZE HER HIP JOINT. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22089930 ↗
• InjuryMay 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HIP REQUIRING REVISION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21992557 ↗
• InjuryApr 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEEPS DISLOCATING. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21899079 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN OF TOTAL HIP ARTHROPLASTY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21162575 ↗
• InjuryJan 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 INFECTION. COMPONENTS WERE EXPLANTED AND REPLACED WITH THE EXACT SAME SIZE. THERE WAS NO HARM DONE TO THE PATIENT. THERE WAS NO SURGICAL DELAY IN THE CASE. PRODUCTS WERE DAMAGED UPON EXTRACTION. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21149856 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON REMOVED THE PROXIMAL BODY, HEAD AND LINER AND IMPLANTED NEW IMPLANTS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 21054785 ↗
• InjuryOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. REMOVED CUP AND WENT BACK. REVISION CUP AND ADDED MORE ANTEVERSION. NO ADDITIONAL INFORMATION. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20369988 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IS SECOND REVISION; CUP, PLASTIC LINER AND HEAD DURING HIP REVISION DOI: (B)(6) 2019, FIRST DOR: (B)(6) 2021, (B)(4). SECOND DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 19589660 ↗
• MalfunctionApr 19, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149640 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED:A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT?NO SURGICAL DELAY IN THE CURRENT PROCEDURE.B. WAS THERE ANY ALLEGATION AGAINST THE SCREWS?NO ALLEGATIONS ON THE SCREWS.C. WAS THERE ANY DISASSOCIATION REPORTED?THE RING WAS DISASSOCIATED .D. WAS THERE ANY ALLEGATION AGAINST CUP?NO ALLEGATIONS AGAINST THE CUP.

  Patient problems: Joint Dislocation

  MAUDE report 19117974 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT WITH POLY AND HEAD WAS EXCHANGED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18172939 ↗
• InjuryMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION AND WAS INFECTED. ALL ACETABULAR COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 16930590 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP. SURGEON EXPLANTED ALL COMPONENTS. DEPUY PARTS WERE ONLY THE STEM. PATIENT HAD A STRYKER CUP. DOI: (B)(6) 2015. DOR: APR 5, 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16784044 ↗
• InjuryMar 31, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THE PATIENT HAD A RIGHT HIP ARTHROPLASTY, TO ADDRESS ADVANCED DEGENERATIVE ARTHRITIS. ON (B)(6) 2021, THE PATIENT HAD A RIGHT HIP REVISION, TO ADDRESS FAILED RIGHT METAL-ON-METAL HIP REPLACEMENT, AND ABDUCTOR TEAR. INDICATIONS FOR SURGERY INCLUDED PAIN, ELEVATED CHROMIUM 1.0 AND ELEVATED COBALT 9.4, AND TORN ABDUCTORS. THERE WAS A SIGNIFICANT AMOUNT OF CORROSION ON THE TRUNNION, THERE WAS METAL WEAR DEBRIS, AND THERE WAS OSTEOLYSIS. THE METAL LINER/HEAD WAS REVISED TO A CERAMIC HEAD AND POLY LINER. ON (B)(6) 2022, MEDICAL RECORDS NOTE THE PATIENT REPORTS HAVING RIGHT HIP FATIGUE CAPTURE ON (B)(4). ON (B)(6) 2022, PATIENT HAD A CLOSED REDUCTION OF DISLOCATED HIP CAPTURE ON (B)(4). ON (B)(6) 2022, THE PATIENT HAD A REVISION OF THE RIGHT THA, TO ADDRESS AN UNSTABLE HIP ARTHROPLASTY. IT WAS NOTED THAT THE PATIENT HAD DISLOCATED THREE TIMES PRIOR TO REVISION. DURING THE REVISION, THE SURGEON OBSERVED THAT THE TISSUE WAS GRAY IN COLOR. DEPUY POLY-CONSTRAINED LINER AS WELL AS DEPUY BIOLOX WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2022, THE PATIENT HAD AN ARTHROCENTESIS RIGHT TROCHANTERIC BURSA DUE TO PAIN, AND THE RIGHT SIDE GREATER TROCHANTERIC BURSA. ON (B)(6) 2022

  Patient problems: Fatigue; Foreign Body Reaction; Joint Dislocation; Joint Laxity; Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 16654903 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATE THAT ON (B)(6)2018: THE PATIENT UNDERWENT A LEFT THA WITH DEPUY IMPLANTS PLACED. IT WAS REPORTED THE PATIENT FELL SEVERAL YEARS LATER AND HAS EXPERIENCED PAIN WITH PROGRESSIVE LOOSENING. (B)(6)2023: PATIENT UNDERWENT A LEFT THA REVISION FOR PAIN, 3CM LIMB DISCREPANCY, DECREASED ROM, POTENTIAL INFECTION, AND FEMORAL STEM LOOSENING AND SUBSIDENCE. BMI-27.98 HEIGHT: 5'4"

  Patient problems: Fall; Loss of Range of Motion; Pain; Physical Asymmetry; Unspecified Infection

  MAUDE report 16537042 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE CUP AT BONE TO IMPLANT INTERFACE. SURGEON ALSO PERFORMED RESECTION ARTHROPLASTY AND INSERTION OF ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Distress; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 15561985 ↗
• MalfunctionSep 19, 2022Noise, Audible; Noise, Audible

  SURGEON REPORTED TO BFARM: "RECURRENCE OF INLAY DISLOCATION AFTER TEP IMPLANTATION ON (B)(6) 2021. FIRST DISLOCATION OF THE INLAY ON (B)(6) 2022, ON (B)(6) 2022 CHANGE OF THE INLAY, ON (B)(6) 2022 ANOTHER INLAY DISLOCATION OCCURRED DURING DEEP BENDING. INTRAOPERATIVELY, NO INLAY COULD BE INSERTED IN A STABILE MANNER IN THE IMPLANTED CUP."

  Patient problems: Insufficient Information

  MAUDE report 15451033 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN IF ANY LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15322505 ↗
• InjuryJun 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS COMPLAINT IS TO CAPTURE THE ADDITIONAL INFORMATION RECEIVED FOR (B)(4) INSTRUMENT CASE: REVISION FOR DISLOCATION : RECLAIM STEM WAS UNABLE TO BE EXPLANTED DUE TO FAILED DISASSEMBLY INSTRUMENT. NO DEPUY PRODUCTS WERE EXPLANTED ON FEMORAL SIDE EXCEPT FOR CERAMIC HEAD WITH TITANIUM SLEEVE. NO DEPUY PRODUCTS WERE EXPLANTED ON FEMORAL SIDE EXCEPT FOR FEMORAL HEAD, RECLAIM STEM AND PROXIMAL BODY REMAINED IN SITU - LOT AND PRODUCT CODE OF FEMORAL HEAD UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14835517 ↗