BIOLOX DELTA 1365-32-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295033417), received between Apr 25, 2018 and Sep 8, 2026 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Device Dislodged or Dislocated

  It was reported that patient had hip replaced sometime ago, date is unknown. Doctor reported patient had severe dementia and experienced several dislocations over the last several months. Doctor opted for complete revision to provide additional stability.DOI: Unknown.DOR: Unknown.Affected side: Right.

  Patient problems: Joint Dislocation

  MAUDE report 50672536 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that more length was needed.DOI: Unknown .DOR: (b)(6)2026.Affected Side: Right Hip.

  Patient problems: Physical Asymmetry

  MAUDE report 50035921 ↗
• InjurySep 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22940507 ↗
• InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. COMPONENTS WERE EXPLANTED. THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. IT DID NOT NEED REPLACEMENT. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21312589 ↗
• InjuryAug 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19990124 ↗
• InjurySep 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED. INDICATES, THAT THE PATIENT HAD HER HIP RELOCATED IN THE EMERGENCY ROOM. THERE WERE NO PREVIOUS SURGERIES, UNTIL THE HIP REVISION WAS PERFORMED.

  Patient problems: Joint Dislocation

  MAUDE report 17772438 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY, HEAD LINER EXCHANGE. AFFECTED SIDE: LEFT HIP. DOI: UNK. DOR: (B)(6) 2023.

  Patient problems: Joint Laxity

  MAUDE report 17342377 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 16844912 ↗
• InjurySep 13, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO LOOSENING. THE PINNACLE LINER ON THE 48 CUP SPUN OUT AND PATIENT CONTINUED TO AMBULATE ON THE CONSTRUCT AND IN DOING SO WORE THE CERAMIC HEAD ON THE CUP CAUSING METALLOSIS AND LOOSE CUP IMPLANT. PICTURES AVAILABLE. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2011. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 15410165 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. HEAD AND LINER WERE EXCHANGED. THERE IS NO REPORTED LOOSENING. NO SURGICAL DELAY. DOI: APR 21, 2022; DOR: MAY 16, 2022; AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 14674727 ↗
• InjuryFeb 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13523090 ↗
• InjuryNov 23, 2021Adverse 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 POSSIBLE INFECTION. DOI : (B)(6) 2021. DOR: (B)(6) 2021. HIP UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12861420 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PUT ON TO EXPLANT A HIP BALL , BIPOLAR SHELL AND A PINNACLE LINER BECAUSE OF INSTABILITY, AND REPLACE WITH A NEW HIP BALL AND A CONSTRAINED LINER. DURING THE PROCEDURE THE SURGEON EXPLANTED THE HIP BALL, BIPOLAR SHELL, AND PINNACLE LINER. THE SROM STEM AND PINNACLE CUP WERE LEFT IN SITU. A NEW 36MM SROM HIP BALL AND A 36MM X 56MM CONSTRAINED LINER WAS IMPLANTED. THE SURGEON WAS SATISFIED WITH THE STABILITY THIS CONSTRUCT PROVIDED. DOI: (B)(6) 2016. DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12605065 ↗
• InjuryAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES PSEUDOTUMOR AND DISLOCATION. DOI: (B)(6) 2015, DOR: (B)(6) 2015, (LEFT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; Joint Dislocation; No Code Available

  MAUDE report 8945768 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED SURGERY ON (B)(6) 2017. 48MM GRIPTION CUP WAS REMOVED WITH A 48X32 NEUTRAL LINER. THE SURGEON REMOVED 32MM +3 FEMORAL HEAD, AND ALSO DECIDED IT WOULD BE BEST TO REMOVE THE 16X11X150 30+4 STEM AND REPLACE IT TO CORRECT THE PATIENT VERSION. PATIENT WAS DEALING WITH HIP DISCOMFORT AND HIP IMPINGEMENT. THE SURGEON DECIDED TO IMPLANT A STRYKER ACETABULAR COMPONENT. AFTER NEW STEM WAS IMPLANTED, A TRIAL REDUCTION WAS PERFORMED WITH 36MM +3 HEAD AND FOUND IT TO BE SATISFACTORY. REAL HEAD WAS IMPLANTED, AND THE CLOSING PROCESS BEGAN. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Discomfort; Joint Disorder; No Code Available

  MAUDE report 8658731 ↗
• InjuryApr 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 8496016 ↗
• MalfunctionApr 25, 2018Fracture; Fracture

  CERAMIC HEAD AND INSERT BREAKAGE. THE INITIAL THAT WAS IMPLEMENTED ON (B)(6) 2012. NO ANOMALY WAS OCCURRED DURING PROCEDURE. ON (B)(6) 2018 THE HIP OF PATIENT FELT PAIN AND PATIENT RETURNED HOSPITAL FOR CHECK. IT INDICATED CERAMIC HEAD AND INSERT BROKE IN X-RAY TEST. THE REVISION SURGERY WILL BE PLANED TO IMPLEMENT ON (B)(6) 2018. NOW PATIENT IS UNDER MONITORING AT HOSPITAL.

  Patient problems: Pain

  MAUDE report 7457720 ↗