BIOLOX® Ceramic Delta Modular Head System 650-1163Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868271571), received between Nov 10, 2022 and Jun 27, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY COMPLETED. APPROXIMATELY 17 MONTHS POST-OP, THE PROSPECTIVE CLINICAL STUDY REPORTED THE PATIENT EXPERIENCED PAIN IN MULTIPLE PLACES ON THE UPPER RIGHT LEG. AN MRI WAS PERFORMED, AND COMPLICATION WAS CONFIRMED TO BE A TROCHANTERIC BURSITIS. THE OUTCOME IS PENDING, AND NO INFORMATION IS YET AVAILABLE ON THE TREATMENT.

  Patient problems: Bursitis; Pain

  MAUDE report 19623119 ↗
• InjuryApr 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION APPROXIMATELY 15 DAYS POST RIGHT TOTAL HIP ARTHROPLASTY AND WAS CORRECTED WITH A CLOSED REDUCTION. SUBSEQUENTLY, THE PATIENT EXPERIENCES THE SECOND DISLOCATION APPROXIMATELY 3 WEEKS LATER WHICH WAS ALSO CORRECTED WITH A CLOSED REDUCTION. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED APPROXIMATELY A MONTH LATER DUE TO RECURRING DISLOCATIONS. PATIENT REPORTS SEVERE PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, DIFFICULTY AMBULATING WITH WALKER AND HAS A LIMP AND DECREASED RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 16830905 ↗
• InjuryNov 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION APPROXIMATELY 15 DAYS POST RIGHT TOTAL HIP ARTHROPLASTY AND WAS CORRECTED WITH A CLOSED REDUCTION. SUBSEQUENTLY, THE PATIENT EXPERIENCES THE SECOND DISLOCATION APPROXIMATELY 3 WEEKS LATER WHICH WAS ALSO CORRECTED WITH A CLOSED REDUCTION. PATIENT REPORTS SEVERE PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, DIFFICULTY AMBULATING WITH WALKER AND HAS A LIMP AND DECREASED RANGE OF MOTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 15770126 ↗
• InjuryNov 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISLOCATION APPROXIMATELY 15 DAYS POST RIGHT TOTAL HIP ARTHROPLASTY AND WAS CORRECTED WITH A CLOSED REDUCTION. SUBSEQUENTLY, THE PATIENT EXPERIENCED THE SECOND DISLOCATION APPROXIMATELY 3 WEEKS LATER WHICH WAS ALSO CORRECTED WITH A CLOSED REDUCTION. PATIENT REPORTS SEVERE PAIN, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, DIFFICULTY AMBULATING WITH WALKER AND HAS A LIMP WITH A DECREASE IN RANGE OF MOTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 15770120 ↗