BIOLOX® Option 650-1068Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887868271502), received between Sep 28, 2021 and Aug 10, 2026 — classified as 9 injuries, 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient reported ongoing extreme pain and swelling after the revision. Attempts have been made, and no further information has been provided.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50190644 ↗
• InjuryDec 22, 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: Bradycardia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 23872268 ↗
• InjurySep 10, 2025Adverse 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: Joint Laxity; Medical device site infection; Periprosthetic fracture

  MAUDE report 23013651 ↗
• MalfunctionMar 13, 2025Difficult to Insert; Separation Failure; Difficult to Insert; Separation Failure

  IT WAS REPORTED THAT DURING THE SURGERY ADAPTER MAY HAVE NOT SEATED CORRECTLY ON THE STEM, WHICH CAUSED THE HEAD TO POTENTIALLY SIT HIGHER THAN IT SHOULD HAVE. THE SURGEON TRIED TO SEPARATE THE HEAD/TAPER FROM THE STEM, BUT THE TAPER REMAINED ON THE STEM WHILE THE HEAD SEPARATED FROM THE TAPER. HE HAD TO REPLACE THAT STEM WITH A NEW STEM AS THE TAPER WOULD NOT DISENGAGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593579 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT HIP REVISION FOR UNKNOWN REASONS; THE SURGEON EXPLANTED FEMORAL HEAD AND ACETABULAR COMPONENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20544931 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO YEARS AND FIVE MONTHS POST INITIAL OPERATION, THE PATIENT UNDERWENT A REVISION DUE TO A HIP DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 19114936 ↗
• InjuryJan 29, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 18594015 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

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

  Patient problems: Bone Fracture(s); Insufficient Information; Joint Dislocation

  MAUDE report 18146715 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE LEFT HIP DUE TO A PSEUDOTUMOR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Local Reaction; Pain

  MAUDE report 15624630 ↗
• MalfunctionDec 17, 2021Difficult to Insert; Activation, Positioning or Separation Problem; Positioning Problem; Difficult to Insert; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED, THAT: SURGEON WAS ABOUT TO IMPLANT THE DUAL MOBILITY HEAD CONSTRUCT, TWO PIECE 28MM HEAD WITH +6 SLEEVE. THE HEAD CONSTRUCT WOULD NOT FILL THE TRUNNION OF THE STEM. TRIALLED WITH A ONE PIECE HEAD TRIAL AND THE TRIAL DID FILL THE TRUNNION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024790 ↗
• MalfunctionNov 22, 2021Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED, THAT: THE PATIENT HAD THE RIGHT TOTAL HIP REPLACED APPROXIMATELY 25 YEARS AGO IN (B)(6). ZIMMER 411 HELPED IDENTIFY LIKELY CUP STEMS MALLORY COMPONENTS. REVISION SURGERY WAS COMPLETED BY DR (B)(6) ON (B)(6) 2021 FOR OSTEOLYSIS AND PAIN IN THE RIGHT HIP. THE CUP AND STEM DID APPEAR TO BE MALLORY. CUP SAID 54 ON IT. THE HEAD WAS A 28 STD JUST SAID STD THAT WE COULD READ. NOTHING OFF THE LINER COULD BE READ. A RINGLOC REPLACEMENT LINER WAS USED SIZE 24. THE DOCTOR FIRST A TYPE ONE REVISION WITH CERAMIC HEAD (+6 SLEEVE AND 16/18 TAPER BIOLOX OPTION 36 HEAD). THE HEAD AND SLEEVE DID NOT APPEAR TO SIT DOWN AS FAR AS THE TRIAL HEAD. THE DOCTOR WAS HESITANT TO IMPACT AS THERE WAS CLOSE TO A 1CM GAP FROM THE END OF THE SLEEVE TO THE END OF THE STEM. THE DOCTOR THEN USED A +9 COCR TYPE ONE 36 HEAD AND IMPACTED. IT ALSO SEEMED TO SIT HIGH ON THE TRUNION. THE DOCTOR ASKED ME TO SEND THE SLEEVE AND NECK IN AND CONFIRM IT IS THE CORRECT SIZE FOR A TYPE ONE TAPER. PATIENT OUTCOME- REVISION.

  Patient problems: Osteolysis; Pain

  MAUDE report 12851497 ↗
• InjurySep 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT THE PATIENT DISLOCATED OVER THE WEEKEND AND WAS REVISED FOR INSTABILITY ON (B)(6) 2021.

  Patient problems: Joint Dislocation

  MAUDE report 12539791 ↗