BIOLOX® delta Modular Ceramic Head 650-1158Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887868271526), received between Sep 28, 2021 and Oct 15, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 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 23279914 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REPLACEMENT SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22912222 ↗
• InjuryAug 11, 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; Medical device site infection

  MAUDE report 22772249 ↗
• InjuryJul 15, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION OF THE LINER AND BEARING. THE SURGEON ATTEMPTED A MANUAL REDUCTION OF THE DISLOCATION AND THEN THE BEARING AND HEAD SEPARATED. ALL COMPONENTS REVISED EXCEPT THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 22505378 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO YEARS POST AN INITIAL LEFT TOTAL HIP ARTHROPLASTY PERFORMED THE PATIENT REPORTED ONGOING MODERATE LOW BACK PAIN THAT WAS NOT PRESENT PRIOR TO THE INITIAL PROCEDURE. IT WAS INITIALLY THOUGHT TO BE GENERAL POSTOP SORENESS; HOWEVER, THE PAIN HAS NOT RESOLVED AND CONTINUES TO LIMIT ACTIVITIES. THE PATIENT HAS SINCE WITHDRAWN FROM THE STUDY TO FOCUS ON THERAPY FOR THE LOW BACK PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 22272224 ↗
• InjuryJan 9, 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 REPLACEMENT ON UNKNOWN DATE. SUBSEQUENTLY, UNDERWENT A REVISION SURGERY DUE TO PAIN/IMPINGEMENT. CERAMIC HEAD WAS REMOVED FROM THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 21112101 ↗
• MalfunctionDec 26, 2024Fracture; Fracture

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020815 ↗
• InjurySep 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant; Joint Dislocation; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 20254751 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027830 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO GREATER TROCHANTERIC FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19497215 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY TOTAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT HAD A FALL AND FRACTURED THEIR FEMUR. THE PATIENT WAS REVISED TWENTY-ONE (21) DAYS POST INITIAL IMPLANTATION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18612834 ↗
• InjuryJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AFTER A FALL APPROXIMATELY 2 MONTHS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 14559977 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  07 APR 2022 UPDATE. IT WAS REPORTED THAT: INITIAL RIGHT HIP HEMIARTHROPLASTY WAS PERFORMED ON (B)(6) 2018 IN AN (B)(6) MALE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A DEEP INFECTION ON (B)(6) 2018. 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). C

  Patient problems: Unspecified Infection

  MAUDE report 14140283 ↗
• MalfunctionJan 19, 2022Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking

  IT WAS REPORTED, THAT THE HEAD WAS STUCK HARD IN THE E1 LINER. DELAY: 0-15 MINUTES, IT TOOK A FEW MINUTES TO REPLACE THE SAME PRODUCT. PATIENT OUTCOME: PROLONGED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287974 ↗
• MalfunctionNov 24, 2021Difficult to Insert; Activation, Positioning or Separation Problem; Positioning Problem; Difficult to Insert; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED, THAT: DELTA CERAMIC HEAD INTO THE E1 BIPOLAR LINER, BUT THE CERAMIC HEAD DID NOT MOVE IN THE E1 BIPOLAR LINER. I WANT TO KNOW WHAT IS HAPPENED FOR THESE ISSUE. PATIENT OUTCOME: PROLONGED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868879 ↗
• InjurySep 28, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED, THAT: DUAL MOBILITY BEARING WAS ASSEMBLY OFF TABLE. CONSTRUCT WAS STABLE AND HEAD WAS MOVING FREELY INSIDE BEARING. THIS CONSTRUCT WAS THEN BROUGHT OVER TO THE PATIENT TO ASSEMBLY ON TRUNION OF STEM. CONSTRUCT WAS PLACED ON TRUNION AND IMPACTED TO ENGAGE, AFTER IMPACTING AND TESTING THE JUNCTION FOR STABILITY THE SURGEON NOTICED THE WHOLE CONSTRUCT CAME OFF, AND A SMALL PIECE OF THE CERAMIC HEAD HAS BEEN CHIPPED OFF. NO CERAMIC PIECES LANDED IN THE PATIENT. PATIENT INVOLVEMENT. ADDI 23 DEC 2021 HOSPITAL DETAILS: (B)(6) HOSPITAL, (B)(6). NO ADDITIONAL INFORMATION ARE AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 12539146 ↗