BIOLOX DELTA 1365-40-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10603295033707), received between Jun 30, 2017 and Aug 5, 2026 — classified as 144 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (48 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 145 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 washout and head and liner exchange for infection.Affected Side: Right Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50140990 ↗
• MalfunctionJun 17, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT AND PASSING INTO THE FIELD THE SURGEON NOTICED SCRATCHES AND DAMAGE TO THE UNDER SURFACE OF THE HEAD. DOE: (B)(6) 2026. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533452 ↗
• InjuryApr 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH DISLOCATED HIP POST COMPLEX REVISION THA. EXISTING CONSTRAINED LINER AND HEAD WERE REMOVED WITHOUT DELAY NOR PATIENT HARM AND NEW COMPONENTS WERE PLACED. PATIENT WAS AGAIN FOUND TO BE EXTREMELY STABLE IN ALL ROM POSITIONS ONCE THE SAME NEW COMPONENTS ARE PLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24971537 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO HIP PAIN COMPLAINT. DOI- (B)(6) 2021. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 24927144 ↗
• InjuryMar 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S HIP DISLOCATED AT HOME. DOCTOR TRIED TO DO A CLOSED REDUCTION UNDER X-RAY, BUT HIP CONTINUED TO DISLOCATE WITH MINIMAL LEG MANIPULATION. DOCTOR REMOVED ACETABULAR COMPONENTS AND REPLACED WITH DUAL MOBILITY FOR MORE STABILITY. DOI: ON (B)(6) 2025. DOR: ON (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 24551679 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL A FEW WEEKS BACK AND OPENED UP THEIR INCISION, WENT TO ER AND HAD IT STAPLED. WOUND OPENED AND STARTED DRAINING SO DOCTOR TOOK BACK TO THE OR FOR AND I&D. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 24256872 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. PATIENT'S PRIMARY RECLAIM MONOBLOC STEM HAD ROTATED WITHIN FEMUR, SO IT WAS REPLACE BY A LONGER RECLAIM MONOBLOC STEM. PATIENT'S PRIMARY FEMORAL HEAD AND ACETABULAR LINER WERE ALSO REPLACED BY DUAL MOBILITY COMPONENTS TO FURTHER STABILIZE THE PATIENT'S HIP. TWO WEEKS PRIOR TO THIS SURGERY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO CONVERT FAILED (CUT OUT) TROCHANTERIC NAIL TO A TOTAL HIP USING DEPUY SYNTHES COMPONENTS. THE TROCHANTERIC NAIL HAD BEEN USED A FEW WEEKS PRIOR TO REPAIR A TROCHANTERIC FEMORAL FRACTURE THE PATIENT HAD SUSTAINED. ALL THREE SURGICAL PROCEDURES WERE PERFORMED BY THE DOCTOR AT THE HOSPITAL. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24225359 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTED RIGHT HIP. PATIENT WAS WASHED OUT, AND HEAD AND LINER WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24178595 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24079690 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL HIP. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 24006753 ↗
• InjuryDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT WAS UNSTABLE WITH DISLOCATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE CUP, LINER, FEMORAL HEAD AND ONE (1) SCREW WERE REMOVED AND REPLACED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23935250 ↗
• InjuryNov 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 RIGHT INFECTED HIP. INCISION AND DRAINAGE. DEPUY HEAD AND COMPETITOR'S LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23583965 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED A GLUTEUS MAXIMUS TEAR AND NEEDED A REPAIR. IN THE PROCESS OF REPAIRING THE TEAR, THE SURGEON NEEDED TO DISLOCATE THE HIP PROSTHESIS AND CHOSE TO IMPLANT A FRESH DM FOR BETTER STABILITY. THE END. NO ISSUE TO IMPLANTS, JUST A SWAP OUT. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23497428 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A WASHOUT/POLY EXCHANGED DUE TO INFECTION. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23490810 ↗
• InjuryNov 5, 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 INFECTED RIGHT HIP. EXTRACTION OF IMPLANTS WERE DONE. STAGE 1 ANTIBIOTIC SPACER PLACEMENT. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23476578 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS I/D HEAD / LINER EXCHANGE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23348070 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hematoma

  MAUDE report 23316320 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS PER SURGEON THE PATIENT HAS INFECTED HIP. SURGEON DID IRRIGATION AND DEBRIDEMENT. RETAINED ALL COMPONENTS AND EXCHANGED HEAD AND LINER. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22577023 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CASES WAS A TOTAL HIP THAT WAS BEING REVISED DUE TO SUSPECTED INFECTION. DR. REMOVED THE 58X40MM +4 PINNACLE LINER AND THE 40MM +5 FEMORAL HEAD AND REPLACED THEM AFTER IRRIGATING WITH A 58X40MM +4 LINER AND A 40MM +8.5 HEAD. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22440704 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 22357950 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS UNSTABLE, A LONGER FEMORAL HEAD WAS IMPLANTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Laxity

  MAUDE report 22308015 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22298980 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I & D OF INFECTED SURGICAL SITE. THERE WAS POLY SWAP AND HEAD LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22286221 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP WASHOUT DEBRIMENT WITH HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22184815 ↗
• InjuryMay 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATED HIP. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 22069104 ↗