BIOLOX® delta Modular Ceramic Head 650-1159Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00887868271533), received between Aug 20, 2021 and Dec 3, 2025 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT AND SUBSEQUENTLY DEVELOPED ONGOING PAIN DURING HIP FLEXION AND EXTERNAL ROTATION, WITH SUSPECTED ILIOPSOAS INVOLVEMENT/IMPINGEMENT. THE PATIENT¿S JOINT WAS LATER REOPENED, AND A SUBSEQUENT PROCEDURE WAS PERFORMED APPROXIMATELY 19 MONTHS POST-IMPLANTATION. DETAILS REGARDING SPECIFIC COMPONENT CHANGES OR INTRA-OPERATIVE FINDINGS WERE NOT PROVIDED. NO ENVIRONMENTAL FACTORS WERE REPORTED. THE PATIENT WAS REVISED; NO FURTHER DETAILS REGARDING THE PATIENT¿S OUTCOME WERE PROVIDED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 23704860 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23311572 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unequal Limb Length

  MAUDE report 22913075 ↗
• InjuryAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 22772245 ↗
• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION DUE TO A DISLOCATION LIMITED SOLELY TO THE FEMORAL HEAD, APPROXIMATELY 18 DAYS POST-IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 22042394 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20406318 ↗
• InjuryAug 20, 2024Noise, Audible; Noise, Audible

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 20004066 ↗
• InjuryMay 23, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE YEAR LATER DUE TO JOINT IMPINGEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Impingement

  MAUDE report 19379766 ↗
• MalfunctionAug 7, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469353 ↗
• InjuryJul 28, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 17413293 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY DUE TO HIP FRACTURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION DUE TO UNKNOWN REASONS AND WAS REDUCED IN THE EMERGENCY DEPARTMENT. LATER ON, THE PATIENT UNDERWENT A HEAD AND LINER EXCHANGE DUE TO AN INTRA-PROSTHETIC DISLOCATION (DISASSOCIATION) WHILE BENDING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17286763 ↗
• InjuryJun 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO CERAMIC HEAD FRACTURE, 3 DAYS AFTER THE INITIAL SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 17206980 ↗
• InjuryMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 17018155 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION 10 DAYS POST HIP ARTHROPLASTY DUE TO LEG LENGTH DISCREPANCY. THE ORIGINAL STEM WAS INSERTED FURTHER, AND THE HEAD WAS EXCHANGED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Unequal Limb Length

  MAUDE report 16521121 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: ON 02-MAR-2022, A JOURNAL ARTICLE WAS RETRIEVED FROM THE JOURNAL OF ORTHOPAEDIC SURGERY (2021) THAT REPORTED A STUDY FROM JAPAN THAT LOOKED AT THE IMPACT OF THE SURGICAL APPROACH ON POSTOPERATIVE DISLOCATIONS. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF HEMIARTHROPLASTY PERFORMED USING THE CPP (CONJOINED TENDON PRESERVING POSTERIOR) APPROACH FOR FEMORAL NECK FRACTURES. THE STUDY REVIEWED 322 PATIENTS WITH FEMORAL NECK FRACTURES. A BIPOLAR HEMIARTHROPLASTY WAS PERFORMED IN ALL PATIENTS USING A PRESS-FIT TAPERLOC STEM AND RINGLOC BIPOLAR CUP. TWO PATIENTS WERE EXCLUDED FROM THE STUDY DUE TO RECEIVING A TOTAL HIP AT THE TIME OF SURGERY, LEAVING 320 PATIENTS FOR FINAL REVIEW. NO PATIENTS WERE EXCLUDED BASED ON AGE, FRAILTY, OR COGNITIVE STATUS. THE STUDY POPULATION HAD A MEAN AGE OF 83.3 YEARS AT THE TIME OF SURGERY (RANGE 57-104) AND A MEAN BMI OF 20.7 (RANGE 11.4-28.9). THE FINAL FOLLOW-UP WAS CONDUCTED AT 9.1 +/- 1.5 MONTHS AFTER SURGERY (RANGE 6-17 MONTHS). COMPLAINT 7: THE STUDY REPORTED AN INITIAL RIGHT HIP HEMIARTHROPLASTY PERFORMED ON (B)(6) 2018 ON A (B)(6) FEMALE. AFTER CLOSING THE WOUND DURING THE INITIAL PROCEDURE, THE PATIENT

  Patient problems: Pulmonary Embolism

  MAUDE report 14315851 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  07 APR 2022 UPDATE: INITIAL RIGHT HIP HEMIARTHROPLASTY WAS PERFORMED ON (B)(6) 2017 IN AN (B)(6) MALE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A SUPERFICIAL INFECTION. THE EVENT WAS NOTED TO HAVE BEEN RESOLVED. NO DETAILS CONCERNING TREATMENT OR INTERVENTION WERE PROVIDED. ON 02-MAR-2022, A JOURNAL ARTICLE WAS RETRIEVED FROM THE JOURNAL OF ORTHOPAEDIC SURGERY (2021) THAT REPORTED A STUDY FROM (B)(6) THAT LOOKED AT THE IMPACT OF THE SURGICAL APPROACH ON POSTOPERATIVE DISLOCATIONS. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF HEMIARTHROPLASTY PERFORMED USING THE CPP (CONJOINED TENDON PRESERVING POSTERIOR) APPROACH FOR FEMORAL NECK FRACTURES. THE STUDY REVIEWED 322 PATIENTS WITH FEMORAL NECK FRACTURES. A BIPOLAR HEMIARTHROPLASTY WAS PERFORMED IN ALL PATIENTS USING A PRESS-FIT TAPERLOC STEM AND RINGLOC BIPOLAR CUP. TWO PATIENTS WERE EXCLUDED FROM THE STUDY DUE TO RECEIVING A TOTAL HIP AT THE TIME OF SURGERY, LEAVING 320 PATIENTS FOR FINAL REVIEW. NO PATIENTS WERE EXCLUDED BASED ON AGE, FRAILTY, OR COGNITIVE STATUS. THE STUDY POPULATION HAD A MEAN AGE OF 83.3 YEARS AT THE TIME OF SURGERY (RANGE 57-104) AND A MEAN BMI OF 20.7 (RANGE 11.4-28.9). THE FINAL FOLLOW-UP WA

  Patient problems: Unspecified Infection

  MAUDE report 14159703 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02-MAR-2022, A JOURNAL ARTICLE WAS RETRIEVED FROM THE JOURNAL OF ORTHOPAEDIC SURGERY (2021) THAT REPORTED A STUDY FROM (B)(6) THAT LOOKED AT THE IMPACT OF THE SURGICAL APPROACH ON POSTOPERATIVE DISLOCATIONS. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF HEMIARTHROPLASTY PERFORMED USING THE CPP (CONJOINED TENDON PRESERVING POSTERIOR) APPROACH FOR FEMORAL NECK FRACTURES. THE STUDY REVIEWED 322 PATIENTS WITH FEMORAL NECK FRACTURES. A BIPOLAR HEMIARTHROPLASTY WAS PERFORMED IN ALL PATIENTS USING A PRESS-FIT TAPERLOC STEM AND RINGLOC BIPOLAR CUP. TWO PATIENTS WERE EXCLUDED FROM THE STUDY DUE TO RECEIVING A TOTAL HIP AT THE TIME OF SURGERY, LEAVING 320 PATIENTS FOR FINAL REVIEW. NO PATIENTS WERE EXCLUDED BASED ON AGE, FRAILTY, OR COGNITIVE STATUS. THE STUDY POPULATION HAD A MEAN AGE OF 83.3 YEARS AT THE TIME OF SURGERY (RANGE 57-104) AND A MEAN BMI OF 20.7 (RANGE 11.4-28.9). THE FINAL FOLLOW-UP WAS CONDUCTED AT 9.1 +/- 1.5 MONTHS AFTER SURGERY (RANGE 6-17 MONTHS). COMPLAINT 13: THE STUDY REPORTED THAT 1 PATIENT EXPERIENCED CEREBRAL INFARCTION (STROKE) IN AN UNKNOWN TIME FRAME POSTOP. THE PATIENT MADE NO RECOVERY AND WAS LOST TO FURTHER FOLLOW UP.

  Patient problems: Stroke/CVA

  MAUDE report 14140240 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A LEFT HIP PROCEDURE ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT SUFFERS FROM HIP PAIN AND STIFFNESS AS WELL AS LIMITED EXERCISE. THE ONSET OF COMPLICATIONS WAS (B)(6) 2021. PATIENT OUTCOME: A PROLONGED EPISODE OF CARE.

  Patient problems: Pain

  MAUDE report 13665923 ↗
• InjuryDec 14, 2021Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED : (B)(6) HOSPITAL PERFORMED A DOUBLE-ACTION TOTAL HIP REPLACEMENT SURGERY ON THE PATIENT ON (B)(6) 2021. POSTOPERATIVE EXAMINATION REVEALED THAT THE PROSTHESIS WAS DISLOCATED INTERNALLY AND THE FEMORAL HEAD WAS DISLOCATED FROM THE LINER, FOLLOWED BY ANOTHER INCISIONAL SURGERY ON (B)(6) 2021 TO REPLACE THE FEMORAL HEAD AND LINER AND THEN REPOSITIONED.

  Patient problems: Joint Dislocation

  MAUDE report 13001305 ↗
• InjuryDec 14, 2021Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT: (B)(6) PERFORMED AA DOUBLE-ACTION LEFT TOTAL HIP REPLACEMENT SURGERY ON THE PATIENT ON (B)(6) 2021. POSTOPERATIVE EXAMINATION REVEALED THAT THE PROSTHESIS WAS DISLOCATED INTERNALLY AND THE FEMORAL HEAD WAS DISLOCATED FROM THE LINER. SUBSEQUENTLY REVISION SURGERY WAS PERFUMED ON (B)(6) 2021 TO REPLACE THE FEMORAL HEAD AND LINER AND THEN REPOSITIONED. NO FURTHER OUTCOME.

  Patient problems: Joint Dislocation

  MAUDE report 12997891 ↗
• InjuryDec 9, 2021Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement; Mechanical Problem; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT: (B)(6) HOSPITAL OF (B)(6) UNIVERSITY PERFORMED A DOUBLE-ACTION TOTAL HIP REPLACEMENT SURGERY ON THE PATIENT ON (B)(6). POSTOPERATIVE EXAMINATION REVEALED THAT THE PROSTHESIS WAS DISLOCATED INTERNALLY AND THE FEMORAL HEAD WAS DISLOCATED FROM THE LINER, FOLLOWED BY ANOTHER INCISIONAL SURGERY ON (B)(6) TO REPLACE THE FEMORAL HEAD AND LINER AND THEN REPOSITIONED. PATIENT INVOLVEMENT: REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 12966219 ↗
• MalfunctionAug 20, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2021, THE BIOLOX DELTA HEAD WAS DIFFICULT TO POSITION WITH THE BIPOLAR LINER. THE DEVICES WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12347036 ↗