BIOLOX DELTA 1365-36-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 10603295033653), received between Jun 27, 2017 and Aug 5, 2026 — classified as 204 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (109 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 206 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to surgeon suspicion of instability. There was no other information known.DOI: Unknown.DOR: Jul 15, 2026Affected side: Left Hip

  Patient problems: Joint Laxity

  MAUDE report 50147245 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HIP HAD DISLOCATED SEVERAL TIMES. THE DOCTOR DECIDED TO TAKE THEM BACK TO SURGERY AND REPLACE THE LINER AND HEAD WITH A CAPTURED LINER. SURGEON SAID THAT NOTHING WAS WRONG WITH OUR COMPONENTS AND JUST THOUGHT IT WAS A PATIENT COMPLIANCE ISSUE WITH THE DISLOCATIONS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23708194 ↗
• InjuryOct 24, 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. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23383219 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A WASHOUT I&D FOR INFECTION. SURGEON ADDED A NEW POLY LINER AND HEAD AFTER WASHOUT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22642959 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 PATIENT WAS ADMITTED FOR TREATMENT OF A PULMONARY EMBOLISM 17 DAYS AFTER A REVISION HIP SURGERY (TO TREAT IMPLANT LINER-CUP DISASSOCIATION). DOE: (B)(6) 2023, AFFECTED SIDE: LEFT HIP. THIS IS A LINK PC OF (B)(4).

  Patient problems: Pulmonary Embolism

  MAUDE report 21996295 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED LEFT HIP. NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21952870 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT I&D. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21761650 ↗
• InjuryFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT WAS CONVERTED TO CONSTRAINED LINER. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21346195 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT THE SECOND STAGE OF A WASHOUT FOR INFECTION. THE SURGEON SWAPPED THE HEAD AND POLY AND WASHED THE PATIENT OUT. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21287236 ↗
• InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. THERE WAS CONVERSION TO DUAL MOBILITY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21160249 ↗
• InjurySep 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD AN IRRIGATION AND DEBRIDEMENT (I&D) HEAD LINER EXCHANGE (B)(6) 2024 AFTER INITIAL SURGERY. SINCE THEN PATIENT HAD DISLOCATED. PATIENT'S HIP WAS CONVERTED TO DUAL MOBILITY. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20226398 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, PATIENT UNDERWENT RIGHT TOTAL HIP REVISION DUE TO ADVERSE TISSUE REACTION TO METAL-ON-METAL PROSTHESIS. DOI: ON (B)(6) 2023. DOR: ON (B)(6) 2023. RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 20007598 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION OF A POLY AND HEAD EXCHANGE. REASON FOR REVISION WAS INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19449460 ↗
• InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION ON (B)(6) 2024 AND UNDERWENT HEAD AND LINER EXCHANGE. THE SURGEON CHANGED THE LINER FACE TO 10 DEGREE LIP. THE PATIENT DISLOCATED AGAIN. THE REVISING SURGEON REVISED THE CUP AND USED DUAL MOBILITY. THE REASON FOR DISLOCATION WAS UNKNOWN. THE ORIGINAL SURGERY DATE IS OVER 10 YEARS AGO. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19300227 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE INFECTION OF HIP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19098931 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED IN (B)(6) 2016 FOR A FAILED METAL ON METAL HIP. PATIENT COMPLAINED OF HIP PAIN. ALL COMPONENTS WERE WELL FIXED EXCEPT THE POLY LINER. IT WAS LOOSE AND HAD SIGNIFICANT WEAR. PATIENT WAS WASHED OUT AND A NEW LINER AND HEAD WERE REPLACED. SALES REP DID NOT KNOW ORIGINAL IMPLANT DATES OR HOSPITAL. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 18949080 ↗
• InjuryJan 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF A PINNACLE CONSTRAINED LINER. ON FRIDAY (B)(6) 2024, WE WERE CONTACTED BY THE ATTENDING PHYSICIAN REGARDING THE DISLOCATION OF A HIP/LINER REVISION TO BE DONE ON SATURDAY MORNING (B)(6) 2024. THE PATIENT HAD A PINNACLE CONSTRAINED LINER (1218-36-656, PIN LNR NEUT (B)(4) WITH A 36MM CERAMIC HEAD BALL (1365-36-710) THAT HAD DISLOCATED. UPON REVIEW OF THE X-RAY, THE HEAD BALL WAS COMPLETELY OUT OF THE LINER. THE CONSTRAINED LOCKING RING WAS STILL FIRMLY ATTACHED TO THE LINER. THE REMOVAL OF THE LINER WAS SUCCESSFUL WITH DAMAGE TO THE LINER, A NEW LINER AND HEAD BALL WAS IMPLANTED WITHOUT INCIDENT.

  Patient problems: Joint Dislocation

  MAUDE report 18519177 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION HEAD AND LINER SWAP. DOI- UNKNOWN. DOR- JANUARY 02, 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18453623 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED, CHANGING THE FEMORAL HEAD AND POSSIBLY THE POLY LINER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP

  Patient problems: Unspecified Infection

  MAUDE report 18010537 ↗
• InjuryOct 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17869287 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AND MASSES WERE NOTED VIA IMAGING AROUND A WELL FIXED UNKNOWN PROSTHESIS. ON (B)(6) 2023, SURGEON DEBRIDED MASSES AND WHEN THE HEAD WAS REMOVED, TRUNNION DEBRIS WAS PRESENT. SURGEON CHOSE TO REPLACE HEAD WITH A DELTA TS IN HOPES THAT THE SIMILAR METALS WOULD REDUCE FURTHER DEBRIS GENERATION. THIS WAS A RELATIVELY EXTENSIVE DEBRIDEMENT AND PATIENT CONTINUED TO HAVE BLOODY DRAINAGE POST SURGICALLY. THIS WAS CAPTURED ON (B)(4). ON (B)(6) 2023, AN I&D AND SURGICAL EXPLORATION TO LOCATE ANY BLEEDERS TOOK PLACE AND THE SURGEON CHOSE TO EXCHANGE HEAD. THERE WAS NO ISSUE WITH THE HEAD, RATHER THE ENVIRONMENT IT HAD BEEN LOCATED IN DUE TO CONTINUED BLEEDING. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 17807125 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. IMPLANTS WERE REPORTED FOR UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED FROM SALES REP STATED: ACTUAL DATE OF REVISION SURGERY WAS (B)(6) 2023. THE PATIENT WAS REVISED TO ADDRESS INFECTION. DEPUY LINER/HEAD/STEM WERE REVISED AND REPLACED WITH DEPUY HEAD/LINER/CEMENT X4 (PROSTALAC). DOI: (B)(6), 2023. DOE: (B)(6), 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17787715 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AND MASSES WERE NOTED VIA IMAGING AROUND A WELL FIXED UNKNOWN PROSTHESIS. ON (B)(6) 2023 SURGEON DEBRIDED MASSES AND WHEN THE HEAD WAS REMOVED, TRUNNION DEBRIS WAS PRESENT. SURGEON CHOSE TO REPLACE HEAD WITH A DELTA TS IN HOPES THAT THE SIMILAR METALS WOULD REDUCE FURTHER DEBRIS GENERATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction

  MAUDE report 17755694 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 17611551 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CONSTRAINED LINER DISLOCATED. DOI: (B)(6) 2023 DOE: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17606954 ↗