BIOLOX DELTA 1365-36-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295033561), received between Oct 6, 2017 and Jun 10, 2026 — classified as 62 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (23 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 62 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 ITEMS WERE EXPLANTED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25457591 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SUSPECTED INFECTION. JOINT WAS WASHED OUT. HEAD AND POLY WERE SWAPPED. APEX HOLE ELIM POSITIVE STOP WAS REMOVED AND NO REPLACEMENT WAS IMPLANTED. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25106387 ↗
• InjuryApr 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HIP DISLOCATION. THE IMPLANTS WERE IDENTIFIED VIA X-RAYS, AND A HEAD AND LINER EXCHANGE WAS PERFORMED USING A CONSTRAINED LINER. A 36+0 HEAD AND A 54 +4 NEUTRAL LINER WERE REMOVED AND REPLACED AFTER CONFIRMING HIP STABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24988440 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE METAL LINER AND HEAD SWAPPED OUT FOR POLY LINER FOR INCREASED METAL ION LEVELS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 21942473 ↗
• InjuryMar 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING AND THE TRUNION OF THE SROM NECK WAS IMPINGING ON THE CUP. THE STEM AND HEAD WERE EXTRACTED. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 21513550 ↗
• InjuryJan 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED FOR DISLOCATION. SURGEON REVISED IMPLANTS TO DM. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21284238 ↗
• InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO CUP POSITION/CHRONIC DISLOCATION. THE SURGEON REVISED THE CUP. THE REMOVED CUP AND LINER REMOVED WERE COMPETITOR PRODUCTS. THE SROM HEAD WAS EXCHANGED FOR A DIFFERENT SIZE. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21162267 ↗
• InjuryNov 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ITEMS EXPLANTED AND REVISED DUE TO DISLOCATION. THERE WAS POTENTIAL MALPOSITIONING AND POTENTIAL PATIENT NON-COMPLIANCE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20750558 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE STUDY PATIENT UNDERWENT SURGERY FOR THE LEFT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: AUGUST 20, 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 20438311 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE STUDY PATIENT UNDERWENT SURGERY FOR THE LEFT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: AUGUST 20, 2024.

  Patient problems: Pulmonary Embolism

  MAUDE report 20438308 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTE AD (B)(6) 2024 WAS REVIEWED BY A CLINICIAN. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT THA DUE TO INCREASING PAIN AND DIFFICULTY WALKING. POST-OPERATIVELY THE PATIENT SUSTAINED AN ACUTE PE IN THE RIGHT LOWER LOBE. SHE WAS TREATED WITH A HEPARIN DRIP. SHE ALSO HAD A NON-OCCLUSIVE DVT IN THE LEFT LEG. THIS WAS LIKELY THE ORIGINAL CLOT FROM THE PE. SHE WENT INTO OBSTRUCTIVE SHOCK FROM THE PE REQUIRING NOREPINEPHRINE IN THE ICU. SHE WAS ALSO DIAGNOSED WITH ENCEPHALOPATHY, ACUTE HYPERCAPNIC AND HYPOXEMIC RESPIRATORY FAILURE, HYPONATREMIA, AND AN ACUTE KIDNEY INJURY. PMH INCLUDES CHF, HYPOTHYROIDISM, MORBID OBESITY, ADHD, AND OBSTRUCTIVE SLEEP APNEA. PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 WITH HOME HEALTH SERVICES.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Pulmonary Embolism; Renal Impairment; Respiratory Failure; Thrombosis/Thrombus

  MAUDE report 20326826 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HIP PAIN, LEG LENGTH DISCREPANCY AND WANTED A REVISION. NO DELAY. DOI: (B)(6) 2023 DOR: (B)(6), 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 20156925 ↗
• InjuryMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? NO, REVISION WENT AHEAD AS PLANNED. B. WHAT WAS THE ALLEGATION AGAINST THE CUP? NO.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 19286409 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2011 (LEFT HIP). TREATMENT: STEM, HEAD, CUP AND LINER WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18486281 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER RIGHT HIP REPLACED BY THE PRIMARY SURGEON ON AUG 24, 2016, WHERE SHE HAD A SROM PINNACLE CONSTRUCT IMPLANTED. SHE WAS DOING WELL UNTIL RECENTLY. THE REVISING SURGEON CONTACTED AND SAID THAT HE HAD A PATIENT WITH A SROM AND NEEDED TO DO A I&D ON HER HIP. DURING THE PROCEDURE, THE 36MM + 0 HIP BALL AND THE 52MM +4 10 DEGREE LINER WAS EXPLANTED. THE SROM FEMORAL SLEEVE, STEM, AND PINNACLE CUP WERE LEFT IN SITU. A THOROUGH I&D WAS DONE AND A NEW FEMORAL HIP BALL AND LINER WAS IMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18483148 ↗
• InjuryJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HIP BECAME DISLOCATED. SURGEON FELT THE PATIENT'S HIP NEEDED TO BE CONSTRAINED. THE LINER AND FEMORAL HEAD WERE REMOVED AND SURGEON REPLACED THEM WITH A CONSTRAINED LINER AND A LONGER LENGTH FEMORAL HEAD. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THERE WAS NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(3) 2017. DOR: (B)(3) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation; Physical Asymmetry

  MAUDE report 18435349 ↗
• InjuryDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A DISLOCATED HIP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18317511 ↗
• InjuryAug 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17642308 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION, HEAD & LINER EXCHANGE. DOI: UNK. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 16897040 ↗
• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 16723244 ↗
• InjuryApr 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION REOCCURRENCE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2013, DATE OF EVENT: (B)(6) 2023, (LEFT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation

  MAUDE report 16662805 ↗
• InjuryNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2012. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15796939 ↗
• InjuryOct 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15606443 ↗
• InjurySep 23, 2022Noise, Audible; Noise, Audible

  UNF AND PINNACLE NON MOM MEDICAL RECORDS RECEIVED. INITIAL REPORTED REASON FOR REVISION ARE THE FOLLOWING FRACTURED PROSTHETIC FEMORAL STEM, PAIN, DISCOMFORT, CLICKING SENSATION, HETEROTOPIC BONE OSSIFICATION, IMPINGEMENT, METALLOSIS, AWAITING FOR MEDICAL RECORDS REVIEW TASK FINDINGS. ONCE AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. DOI: (B)(6) 2010; DOR: (B)(6) 2014 ; LEFT HIP.

  Patient problems: Discomfort; Extraskeletal ossification; Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 15474045 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO ADDITIONAL DETAILS. NO SURGICAL DELAY. DOI: (B)(6) 2017; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 15439741 ↗