Biolox® delta 00-8775-036-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024430389), received between Nov 13, 2019 and May 2, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 8 MONTHS POST IMPLANTATION DUE TO THE PATIENT HEARD A CRACKING SOUND AND UPON SITTING HEARD A WEIRD SOUND AND IMMEDIATELY FELT SOMETHING WAS WRONG. IT WAS LATER FOUND THAT THE HEAD COMPONENT HAD FRACTURED, AND THE PATIENT WAS REVISED APPROXIMATELY 8 MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 21950880 ↗
• InjuryMar 19, 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. SUBSEQUENTLY, PRIOR TO OUTPATIENT DISCHARGE, POST-OPERATIVE ORTHOSTATIC HYPOTENSION AND A RIGHT POSTEROLATERAL HEMATOMA WERE NOTED. THE PATIENT WAS TRANSFERRED FROM THE SURGERY CENTER AND ADMITTED TO A HOSPITAL FACILITY FOR OBSERVATION AND MEDICAL INTERVENTION. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE STUDY HAS SINCE BEEN COMPLETED PER PROTOCOL WITH NO FURTHER COMPLICATIONS OR ALLEGATIONS AGAINST THE DEVICE, ALL INITIAL PRODUCT REMAINS IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 18928621 ↗
• InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 18827428 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SMALL FEMORAL FRACTURE WAS NOTED AND SECURED WITH CERCLAGE WIRE WHEN IMPLANTING THE CLS STEM. THEN, ON POST-OP X-RAYS THE FRACTURE WAS FOUND TO BE MUCH WORSE AND REQUIRED FURTHER SURGERY. CLS STEM WAS REMOVED, AND FRACTURE STABILIZED WITH WIRES ON REVISION SURGERY. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 18475361 ↗
• InjurySep 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE AND SUBSEQUENTLY HAD TO UNDERGO A REVISION THE NEXT DAY DUE TO A DISLOCATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Joint Dislocation

  MAUDE report 17734464 ↗
• MalfunctionApr 25, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE CERAMIC HEAD, THE STERILE PACKAGING WAS FOUND TO BE DAMAGED CAUSING A STERILITY BREACH. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805112 ↗
• InjuryMay 30, 2022Unstable; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT: THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 1 MONTH AFTER THE IMPLANTATION DUE TO PERIPROSTHETIC INSTABILITY AND BONE FRACTURE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 14539625 ↗
• InjuryApr 11, 2022Fracture; Fracture

  REVISION DUE TO IMPLANT FRACTURE. IT WAS REPORTED THAT THE CERAMIC HEAD FRACTURED AND BROKE IN THE PATIENT. PATIENT OUTCOME - REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 14074942 ↗
• InjuryOct 7, 2021Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Scar Tissue

  MAUDE report 12589524 ↗
• InjuryNov 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9390019 ↗
• MalfunctionNov 13, 2019Packaging Problem; Packaging Problem

  PLEASE REFER TO REPORT 0009613350-2019-00676.

  Patient problems: No Information

  MAUDE report 9314588 ↗