BIOLOX DELTA 1365-28-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 10603295033271), received between Jun 28, 2017 and Sep 28, 2026 — classified as 158 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (55 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 169 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50918032 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50144528 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to infection.DOI: (b)(6)2026.DOR: (b)(6)2026.Affected side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50074539 ↗
• InjuryMay 27, 2026Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT BILATERAL THA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. TWO YEARS AFTER THE SURGERY, CRACKS AT THE STEM NECKS WERE IDENTIFIED ON RADIOGRAPHIC IMAGING. THE PATIENT IS A BALLET DANCER AND WAS ABLE TO PERFORM BALLET MOVEMENTS, INCLUDING ABDUCTION; HOWEVER, IT WAS REPORTED THAT A SOUND SUGGESTIVE OF IMPLANT IMPINGEMENT OCCURRED WHEN THE HIP WAS BROUGHT TO MAXIMUM ABDUCTION. AT PRESENT, THE PATIENT REPORTS NO PAIN OR FUNCTIONAL ISSUES. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) CAPTURES FOR THE LEFT HIP AND (B)(4) CAPTURES FOR THE RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 25301398 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 25013742 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISED DUE TO INFECTION. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24875415 ↗
• InjuryApr 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR DISLOCATION AND DISSOCIATION OF BIPOLAR HEAD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24838706 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ORIGINAL CASE WAS DONE SEVEN YEARS AGO DUE TO INSTABILITY. PATIENT DISLOCATED PINNACLE CONSTRAINED LINER. DOCTOR STATED THAT THE CUP WAS NOT IN AN OPTIMAL POSITION AND WAS VERTICAL. THERE WAS VISIBLE IMPINGEMENT BETWEEN THE CUP AND TRUNION. NOTICEABLE METALOSIS ON THE TISSUES. DOCTOR CUT OUT THE PINNACLE CUP AND REPLACED IT WITH A REDAPT CUP; REMOVED THE HEAD, CUP, LINER AND SCREWS. REPLACED WITH A +12 TO INSURE STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Joint Laxity

  MAUDE report 23803882 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR HIP REVISION - INFECTION. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: ON (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 101854018, LOT NUMBER: 4442962, COMPONENT TYPE: STEM, DESCRIPTION: RECLAIM MONOBLOC REVISION STANDARD STEM 18 STANDARD OFFSET. CATALOG NUMBER: 473246028, LOT NUMBER: 4838000, COMPONENT TYPE: HEAD, DESCRIPTION: EMPHASYS 46 MM X 28 MM AOX MOBILE BEARING HEAD. CATALOG NUMBER: 472556046, LOT NUMBER: 4671538, COMPONENT TYPE: LINER, DESCRIPTION: EMPHASYS 56-58 MM X 46 MM DUAL MOBILITY LINER. CATALOG NUMBER: 471056300, LOT NUMBER: 4925729, COMPONENT TYPE: SHELL, DESCRIPTION: EMSYS SHL 3HOLE 56. CATALOG NUMBER: 121735500, LOT NUMBER: PU209417, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 35MM. CATALOG NUMBER: 121745500, LOT NUMBER: PU216737, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 45MM. CATALOG NUMBER: 136528310, LOT NUMBER: 4369950, COMPONENT TYPE: HEAD, DESCRIPTION

  Patient problems: Unspecified Infection

  MAUDE report 23523377 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A BHA SURGERY FOR FEMORAL NECK FRACTURE ON THE LEFT HIP JOINT WITH THE PRODUCT IN QUESTION. IN THE SURGERY, WHEN THE PRODUCT WAS INSERTED, THE HEAD BROKE WHEN IT WAS HIT WITH AN IMPACTOR. A DIFFERENT PRODUCT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512866 ↗
• 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23378114 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED, SO THE SURGEON WASHED THE IMPLANT OUT AND SWITCHED THE METAL AND POLY LINERS AND THE HEAD. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23040223 ↗
• InjurySep 9, 2025Fracture; Noise, Audible; Fracture; Noise, Audible

  INFORMATION WAS RECEIVED FROM THE DOCTOR THAT REVISION SURGERY WAS NEEDED FOR A PATIENT WITH A DESTROYED BIOLOX DELTA CERAMIC HEAD. COMPLAINTS WERE OF CRUNCHING, INSTABILITY AND PAIN IN THE HIP JOINT. THE PATIENT'S CURRENT CONDITION IS SATISFACTORY DOI: (B)(6) 2013. DOR: (B)(6) 2025.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23004995 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, THE HEAD, LINER AND PROXIMAL BODY WERE REMOVED AND REPLACED AFTER WASHOUT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22979714 ↗
• InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ZIMMER LINER WAS REVISED TO A CONSTRAINED DUE TO NON-COMPLIANCE AND MULTIPLE DISLOCATIONS. SURGEON OPTED TO GO CONSTRAINED WHICH REQUIRED A LARGER OD HEAD TO ACCOMMODATE THE NEW LINER. SURGEON REMOVED THE 28 HEAD AND USED A METAL 36 DIAMETER HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22947338 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CONVERSION FROM A GAMMA NAIL TO A THR. PATIENT GOT INFECTED 6 WEEKS POSTOPERATIVELY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22819977 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH WASHOUT AND POLY SWAP FOR POST OPERATIVE DRAINAGE. THERE WAS NO ALLEGATION AGAINST IMPLANTS. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fluid Discharge

  MAUDE report 22736293 ↗
• InjuryJun 27, 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 NEED FOR INCREASED OFFSET AND LEG LENGTH. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 22344817 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DR PERFORMED I&D WASHOUT AND HEAD EXCHANGE FOR POSSIBLE INFECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22344234 ↗
• InjuryJun 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22289433 ↗
• InjuryJun 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLOCATION OCCURRED. UPON TRYING TO REDUCE IN THE ER, FEMUR FRACTURED BELOW THE STEM.

  Patient problems: Joint Dislocation

  MAUDE report 22236474 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIP I&D FOR SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM INFECTION. DEPUY FEMUR AND HEAD AND COMPETITOR LINER AND CUP WERE USED. THE STEM WAS NOT REVISED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22153391 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS BIPOLAR HEMI WITH SUMMIT PF STEM. PATIENT HAS RECURRENT ANTERIOR INSTABILITY WITH DISLOCATION. THE SURGEON PERFORMED REVISION HEMI TO TOTAL ARTHROPLASTY. NO LOOSENING. STEM WELL FIXED. NO SURGEONS COMPLAINTS OF IMPLANT. NO CASE DELAY. NO BROKEN PIECES. NO OTHER INFORMATION KNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22104250 ↗
• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SALES REP ATTENDED A GIRDLE STONE OPERATION DUE TO AN INFECTION. THE DETAILS LEADING UP TO THE GIRDLE STONE OPERATION ARE AS FOLLOWS: (B)(6) 2023, THE PATIENT HAD A SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR AND UNDERWENT INITIAL SURGERY WITH A NAIL. IT IS UNKNOWN WHETHER THE NAIL WAS A J&J¿S PRODUCT OR NOT. ON (B)6) 2024, THE PATIENT HAD A SECOND SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR. THE NAIL BREAKAGE ALSO OCCURRED. AN ARTIFICIAL HEAD REPLACEMENT AND ORIF WITH THE IMPLANTS IN QUESTION WAS PERFORMED. ON (B)(6) 2024, DISLOCATION WAS OBSERVED. 2ND WEEK OF (B)(6) 2025, THERE WAS REDNESS AROUND THE WOUND AND SWELLING, AND EXUDATE WAS CONFIRMED FROM THE WOUND, SUGGESTING INFECTION AROUND THE STEM. ON (B)(6) 2025, CONSIDERING THE PATIENT'S MEDICAL HISTORY AND DECLINE IN ADL, THE GIRDLE STONE OPERATION (WHICH WAS SCHEDULED FOR REMOVAL OF ALL IMPLANTS) WAS PERFORMED. THE STEM WAS PRESERVED BECAUSE IT WAS STUCK. THE GIRDLE STONE OPERATION WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT'S MEDICAL HISTORY, AND OTHER DISEASES CURRENTLY BEING TREATED, ETC.: ALCOHOLIC CIRRHOSIS, ANXIETY DISORDER, INSOMNIA, STASIS DERMATITIS, RIGHT CON

  Patient problems: Anxiety; Erythema; Joint Dislocation; Swelling/ Edema; Unspecified Infection

  MAUDE report 22048125 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS LOOSENING OF STEM AT UNKNOWN INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22009640 ↗