BIOLOX DELTA 1365-32-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10603295033479), received between Jun 28, 2017 and Aug 31, 2026 — classified as 103 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (62 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 105 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised due to hip dislocation. The doctor removed liner and head and replaced with a constrained liner and new head for appropriate length. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50532054 ↗
• InjuryAug 27, 2026Device Dislodged or Dislocated

  It was reported that Patient suffered a dislocation. Dr informed me that the patient would like to perform a head and liner exchange. The patient was already implanted with a DePuy constrained liner and 32 +5 TS ceramic head. Those components were removed. Dr was unsure of when that revision took place or when the original surgery date was. Once those implants were removed, a new constrained liner was opened and implanted. The patient opted to go with a +4 neutral constrained liner this time as opposed to the +4/10 degree. A new TS 32+5 head was implanted and reduced. Stability was confirmed and the closing process began. No delays or adverse events took place.Activity Level, yes.DOI. Unknown.DOR. (b)(6) 2026.Affected side. Right.

  Patient problems: Joint Dislocation

  MAUDE report 50476109 ↗
• InjuryFeb 20, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR ANOTHER COMPONENT EXCHANGE. PATIENT HAD EXTENSIVE HEAD AND POLY WEAR A SECOND TIME. THE DOCTOR EXPLANTED CUP TO REPOSITION. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 24399390 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OCCURRED ON (B)(6) 2025 DUE TO INFECTION DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23743030 ↗
• InjuryOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO CONSTRAINED LINER DUE TO RECURRENT DISLOCATIONS. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23368666 ↗
• InjurySep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23074752 ↗
• InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22797647 ↗
• InjuryFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A DISLOCATED HIP. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21445394 ↗
• InjuryNov 13, 2024Adverse 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 HIP, REQUIRING A HEAD AND LINER EXCHANGE. THERE WAS NO DELAY, AND THERE WERE NO ADVERSE CONSEQUENCES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20674761 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 19732220 ↗
• InjuryApr 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY AND HEAD WERE REMOVED AND REPLACED WITH DUPLICATE SIZES. THERE WAS NO HARM DONE TO PATIENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2024. ADDITIONAL EVENT INFORMATION: PATIENT WAS REPORTING THIGH PAIN, THERE WAS NO DEFECT IN THE HEAD AND LINER. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 19115335 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 18827107 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO HARM TO THE PATIENT, ONLY 1 SCREW WAS REMOVED.

  Patient problems: Discomfort

  MAUDE report 18747579 ↗
• InjuryDec 19, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  IT WAS REPORTED THAT THE SURGEON STATED THAT HIS PATIENT WAS HEARING SQUEAKY NOISE COMING FROM HER HIP. AFTER AN X-RAY WAS TAKEN HE NOTICED THAT THE HEAD BALL WAS MALPOSITION. PATIENT WAS REVISED WITH DUAL MOBILITY. CHART NOTES AND X-RAYS TO FOLLOW. IT WAS ALSO INDICATED THAT THERE WAS MALPOSITION OF THE CUP. DOI: (B)(6) 2019 - DOR: DEC 14,2021 (UNKNOWN SIDE). MRR FINDINGS, AEI NOTE A-10291640 UNDER (B)(4). ON (B)(6) 2022, THE PATIENT HAD A REVISION RIGHT TOTAL HIP TO ADDRESS FRACTURED, DISLOCATED, DEFORMED POLYETHYLENE LINER, METALLOSIS IN SURROUNDING TISSUE. HEAD AND LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Joint Dislocation; Pain; Swelling/ Edema

  MAUDE report 18356168 ↗
• InjuryDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEEPS DISLOCATING SO A CONSTRAINED LINER WAS PUT IN. UNKNOWN SURGICAL DELAY. (B)(6). AFFECTED SIDE: RIGHT HIP

  Patient problems: Joint Dislocation

  MAUDE report 18275585 ↗
• InjuryNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVE: A. PLEASE CONFIRM WAS THE REVISION SURGERY HAPPENED SUCCESSFULLY? IF YES, PLEASE PROVIDE THE DETAILS. YES, THIS REVISION SURGERY WAS SUCCESSFUL. SURGEON IMPLANTED NEW GRIPTION CUP WITH PINNACLE DUAL MOBILITY CONSTRUCT. THE REASON WAS HE WANTED TO PROTECT AGAINST FUTURE DISLOCATION POST OP. HE ALSO IMPLANTED A REVISION CERAMIC HEAD ONTO THE IN SITU STEM. THE STEM WAS NOT REVISED.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 18143095 ↗
• InjurySep 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17842701 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17798381 ↗
• InjuryAug 24, 2023Adverse 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. SHE HAS MS AND WAS NOT STABLE WITH A STANDARD HIP CONSTRUCT SO THE SURGEON CONVERTED THE 50X32 +4 10 DEGREE LINER TO A CONSTRAINED 50X28 +4 10 DEGREE LINER. THE HEADS WERE CHANGED FROM A 32MM +5 TO A 28MM +5 TS CERAMIC HEAD. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6). AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 17611040 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. IT WAS REPORTED THAT THE IMPLANT WAS NOT THE ISSUE. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17602887 ↗
• InjuryJul 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HER LEFT HIP REPLACED ALMOST A YEAR AGO WHERE A SUMMIT AND PINNACLE CUP WAS IMPLANTED. THIS PATIENT DID WELL INITIALLY BUT RECENTLY DISLOCATED HERE HIP SEVERAL TIMES. NO DATES GIVEN FOR WHEN THIS PATIENT DISLOCATED AND WAS REDUCED IN THE ER AND OR. THE DECISION WAS MADE TO REVISE THIS PATIENTS CUP AND IMPLANT A NEW CUP WITH LESS ANTEVERSION TO MAKE THIS CONSTRUCT MORE STABLE. SURGEON EXPLANTED THE PATIENTS ACETABULAR CUP, LINER, AND FEMORAL HIP BALL AND IMPLANTED A ZIMMER G7 CUP. THE LOTT #¿S FOR THE HIP BALL AND LINER WERE NOT LEGIBLE BECAUSE OF DAMAGE FROM DISLOCATION AND BEING EXPLANTED WITH OSTEOTOMES. THE SUMMIT STEM WAS LEFT IN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17395715 ↗
• InjuryJun 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A 36MM HEAD. A 32MM HEAD WAS ORIGINALLY IMPLANTED BY MISTAKE. A 52 CUP WITH A 52X36 LINER WAS IMPLANTED. DOI: (B)(6) 2023 . DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17215621 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY, AND THERE WAS NO HOLE ELIMINATOR OR CEMENT USED IN THE ORIGINAL SURGERY OR PREVIOUS REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 17191749 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUBLUXATION. THE LINER AND HEAD WILL BE REPLACED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16889872 ↗
• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT'S ACETABULAR LINER AND FEMORAL HEAD WAS REVISED DUE TO RECURRENT DISLOCATIONS. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16723873 ↗