BIOLOX DELTA 1365-28-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295033318), received between Dec 11, 2017 and Jun 10, 2026 — classified as 59 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (30 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ALL COMPONENTS IN AN INFECTED TOTAL JOINT WITH AN ACETABULAR FRACTURE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25461470 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SEVERE BONE LOSS AND SURGEON LEFT THE PATIENT FOR GIRDLE STONE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Notching

  MAUDE report 25058898 ↗
• InjuryApr 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT WAS REVISED TO ADDRESS RECURRENT RIGHT TOTAL HIP INSTABILITY (DISLOCATIONS) AND CHRONIC ABDUCTOR DYSFUNCTION SECONDARY TO GREATER TROCHANTER FRACTURE NON-UNION, WITH INSUFFICIENT BONY BED ALONG THE LATERAL PROXIMAL FEMUR TO ATTEMPT INTERNAL FIXATION OF THIS FRACTURE. PATIENT WAS TREATED WITH REVISION OF THE MODULAR FEMORAL HEAD AND ACETABULAR LINER TO A CONSTRAINED ARTICULATION. CUP AND FEMUR WERE WELL-FIXED AND RETAINED. THERE WERE NO COMPLICATIONS. DISLOCATION #1 ON (B)(6) 2024: PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH RIGHT HIP PAIN. PATIENT HAD KNELT DOWN TO PULL UP HER SOCK WHEN SHE FELT A SUDDEN "POP" SENSATION IN HER RIGHT HIP, EXPERIENCING PAIN 10 ON 1-10 SCALE. ON (B)(6) 2024: OFFICE POST-OP FOLLOW-UP APPOINTMENT: SURGEON NOTED POSTOPERATIVE COURSE WAS COMPLICATED BY PATIENT HAVING DEVELOPED FOOT DROP WITH DIMINISHED SENSATION IN HER SCIATIC NERVE DISTRIBUTION, WHICH WAS CONCERNING FOR SCIATIC NERVE NEUROPRAXIA VERSUS PALSY SECONDARY TO LOCAL ANESTHETIC INFILTRATION NEAR THE NERVE.¿ NEUROPRAXIA IS A FORM OF PERIPHERAL NERVE INJURY CAUSED BY COMPRESSION OR STRETCH WHICH MAY RESOLVE SPONTANEOUSLY WITHIN WEEKS OR MONTHS OF INJURY. ALSO PRESENTED

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24951596 ↗
• InjuryFeb 17, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. B. PLEASE CONFIRM WAS THERE PREVIOUS REVISION/S DUE TO MULTIPLE DISLOCATIONS? IF YES, WAS THIS REPORTED? PLEASE PROVIDE THE REFERENCE NUMBER. IF NO, PLEASE PROVIDE FURTHER DETAILS. YES REVISED ON (B)(6) 2025, AND AGAIN ON (B)(6) 2025 TO A CONSTRAINED LINER. C. WAS THERE ANY ALLEGATION AGAINST THE CUP AND STEM? NO. D. PLEASE CONFIRM HOW MANY PREVIOUS SURGERIES HAPPENED. 4. E. PLEASE PROVIDE REASON WHY THE STEM/CUP WAS REVISED, WAS THERE AN INDICATION THAT THE STEM/CUP WAS MALPOSITIONED THAT CONTRIBUTED TO DISLOCATION? ONLY THE POLY AND HEAD WAS REVISED. F. PLEASE CLARIFY IF THE PREVIOUS MULTIPLE SURGERIES FOR DISLOCATION INVOLVED REMOVAL OF DEPUY PRODUCTS. IF YES, WAS THIS REPORTED? PLEASE PROVIDE THE REFERENCE NUMBER. IF NO, PLEASE PROVIDE FURTHER DETAILS. YES, EVERY REVISION WAS A HEAD AND LINER EXCHANGE TO MAKE THE HIP MORE STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 24363577 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE SURGEON PERFORMED HEAD AND LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23837548 ↗
• InjuryDec 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF HIP FROM CONSTRAINED LINER. SURGEON SAID THE PATIENT STEM AND CUP WERE NOT ALIGNED CORRECTLY BUT GIVEN ITS AGE SURGEON DID NOT WANT TO REMOVE THE IMPLANTS. SURGEON DID NOT DO THE PRIMARY SURGERY AND BELIEVED CHANGING OUT FOR THE SAME CONSTRAINED LINER SHOULD KEEP PATIENT STABLE. SURGEON SAID NOTHING LOOKED WRONG WITH OUR COMPONENTS JUST THAT THEY WERE NOT ALIGNED CORRECTLY. BOTH WERE IN RETROVERSION. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23790444 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POSSIBLE INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23747110 ↗
• InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND UNDERWENT REVISION SURGERY FOLLOWING DISLOCATION OF CONSTRAINED LINER HIP. DURING SURGERY THE LOCKING RING WAS FOUND TO HAVE CRACKED ON THE CONSTRAINED LINER. PATIENT ALSO HAD SOME METALLOSIS IN THE HIP REGION. PATIENT WAS REVISED WITH DEPUY DUAL MOBILITY HIP LINER AND NEW CERAMIC HEAD FOR STABILITY. NO FURTHER INFORMATION AVAILABLE ON HOW HIP DISLOCATED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Pain

  MAUDE report 23584872 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT I/D WASHOUT. PATIENT WAS INFECTED. THERE WAS NO COMPLICATIONS DURING SURGERY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22631832 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REVISION SURGERY TO REPLACE CONSTRAINED POLY LINER THAT HAD CRACKED DUE TO FEMORAL NECK IMPINGEMENT. FEMORAL HEAD 28MM +5 WAS REPLACED WITH SAME SIZE FEMORAL HEAD 28MM +5 CERAMIC. SAME SIZE PINNACLE CONSTRAINED LINER 50MM X 28MM NEUTRAL +4 THAT WAS REMOVED WAS ALSO REPLACED.

  Patient problems: Joint Laxity

  MAUDE report 22589074 ↗
• InjuryJul 18, 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 INSTABILITY. JUST A HEAD EXCHANGE FOR US. THE PATIENT HAD A COMPETITOR'S CUP IN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22540339 ↗
• InjuryJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A PINNACLE CONSTRAINED LINER IMPLANTED IN 2022 FOR CHRONIC DISLOCATION. PATIENT BROKE THE POLY/RING LOCKING MECHANISM RECENTLY AND DISLOCATED AGAIN. DOCTOR ELECTED TO PUT A NEW PINNACLE CONSTRAINED LINER IN. DOCTOR HAD PUT IN A CONSTRAINED LINER IN 2012 AND AGAIN IN 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22370624 ↗
• InjuryJun 2, 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. NO FURTHER INFORMATION AVAILABLE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22122475 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025, DOR: (B)(6)2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21881704 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHICH HAS MADE THEM VERY ILL. INFECTION IN THE JOINT HAS SINCE DEVELOPED, AS SURGEON NOTED PATIENT HAD BEEN DOING WELL BEFORE THE ABOVE INFECTION. A REVISION OF RIGHT THA DUE TO INFECTION FOLLOWING A DAIR WAS PERFORMED. PATIENT STILL HAD INFECTION AND REQUIRED FIRST STAGE REVISION TO REMOVE ALL COMPONENTS, WASH OUT AND DEBRIDEMENT. CEMENTED A 52 LINER AND SIZE 1 C STEM PLACED FOR APPROXIMATELY 6 WEEKS, AND WILL THEN FULLY REVISE.

  Patient problems: Unspecified Infection

  MAUDE report 21138853 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REGISTRAR CONDUCTING A DAIR ON A PATIENT WITH PINNACLE DM. PRIMARY REASON FOR REVISION WAS DUE TO INFECTION WITHIN THE JOINT. PATIENT'S SURGERY WAS CONDUCTED. DM LINER WAS NOT REMOVED ONLY POLY HEAD AND FEMORAL HEAD. PATIENT EXPERIENCED INFECTION, READMISSION TO HOSPITAL AND WASH OUT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 21103008 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DEEP INFECTION IN THE CUP OF A TOTAL HIP IN 2012. CUP AND HEAD WERE REPLACED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20878635 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DISLOCATED POST REVISION THA. PATIENT HAS A FUSED SPINE AND HAS SIGNIFICANT BACK PAIN. COMPONENTS ARE FOUND TO BE WELL POSITIONED HOWEVER DUE TO PATIENT REQUEST AND HIS LACK OF COMPLIANCE WITH POST OPERATIVE MOVEMENTS DUE TO HIS BACK PAIN, WAS CONVERTED TO A CONSTRAINED LINER. THERE WAS NO DELAY NOT PATIENT HARM. METAL DM LINER WAS PLACED ON (B)(6) 2024. POLY DM LINER AND HEAD WERE PLACED ON (B)(6) 2024 DUE TO POSTOPERATIVE DRAINAGE AND SURGEON CHOSE TO EXCHANGE THESE DUE TO INFECTION RISK. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 20855101 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 20662461 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TO REVISE DUE TO PAIN AND IMPINGING ON THE CUP. HE HAD NOT DISLOCATED YET BUT WAS PAINFUL. CUP WAS VERTICAL AND THE STEM WAS UNDERSIZED. CUP AND STEM WERE REMOVED AND REPLACED WITH LARGER SIZE IMPLANTS. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20268897 ↗
• InjuryJul 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA THA FOR THE HIP JOINT WITH THE IMPLANT IN QUESTION. ON (B)(6) 2024, A REVISION SURGERY WAS PERFORMED TO REPLACE THE HEAD DUE TO DISLOCATION. THE DISLOCATION WAS CONTROLLED DURING THE INTRAOPERATIVE REDUCTION, BUT RE-DISLOCATED WHEN THE IMPLANT WAS PLACED. THE INSTALLATION POSITION OF THE STEM IN THE ANTERIOR TORSIONAL POSITION WAS THOUGHT TO BE A CAUSE OF THE PROBLEM. THEREFORE, THE STEM WAS REMOVED AND REPLACED WITH A CEMENT STEM MADE BY ANOTHER COMPANY. THE DISLOCATION WAS RETURNED TO ITS ORIGINAL POSITION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2024. DOE: (B)(6) 2024.

  Patient problems: Hepatitis; Joint Dislocation

  MAUDE report 19739812 ↗
• InjuryApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DIE TO DISLOCATION. HEAD / LINER WERE EXCHANGE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19080533 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CULTURES FROM REVISION ON (B)(6) 2024 CAME BACK POSITIVE FOR A STAPH INFECTION. CURRENT IMPLANTS WERE REMOVED SO THAT THE INFECTION COULD BE TREATED, AND THEN REPLACED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18970180 ↗
• InjuryMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REÇLAIM STEM IN PLACE WAS NOT THE ISSUE OF CONCERN. THE RECLAIM STEM IN PLACE WAS SOLIDLY FIXED AND WELL POSITIONED, THUS THE FEMORAL STEM WAS RETAINED. ONLY THE FEMORAL HEAD WAS EXCHANGED FOR A DIFFERENT SIZE AND LENGTH.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 18858083 ↗
• InjuryDec 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT CHRONICALLY DISLOCATED AND ELECTED TO CONVERT TO A DIFFERENT VENDOR CUP. DEPUY CUP, LINER AND HEAD WAS REMOVED. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE : LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18283229 ↗