BIOLOX® delta Modular Ceramic Head 650-0662Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00887868271182), received between Sep 7, 2020 and Dec 9, 2025 — classified as 24 injuries, 3 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: Joint Contracture; Unequal Limb Length

  MAUDE report 23756984 ↗
• InjuryOct 29, 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: Bone Fracture(s)

  MAUDE report 23413212 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY LEGAL THAT A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED APPROXIMATELY FOUR YEARS AND THREE MONTHS AGO. THE PATIENT DID WELL UNTIL TWO YEARS POSTOP WHEN HE WAS MOVING A BOX AND LEANING FORWARD AND FELT SOMETHING POP IN HIS HIP. IMMEDIATE X-RAYS DID NOT SHOW ANY ACUTE FINDINGS. THREE WEEKS LATER, THE PATIENT PRESENTED WITH PROGRESSIVE PAIN, SQUEAKING, SWELLING, AND REDNESS IN THE HIP. X-RAYS SHOWED THE FEMORAL HEAD ARTICULATING AGAINST THE CUP WITH POLY LINER DISSOCIATION AND SUBSIDENCE. ELEVATED CRP LEVELS INCREASED CONCERN FOR INFECTION, SO THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT WITH HEAD AND LINER EXCHANGE APPROXIMATELY RWO YEARS AGO. DURING THE REVISION, SIGNIFICANT METALLOSIS WAS IDENTIFIED THROUGH A TEAR IN THE FASCIA WHICH TRACKED DOWN INTO THE HIP. NECROTIC TISSUE AND PIECES OF LOOSE POLY WERE REMOVED FROM THE HIP. THE HIP WAS THOROUGHLY IRRIGATED, AND A NEW HEAD AND LINER WERE PLACED WITHOUT COMPLICATIONS. THE INITIAL STEM AND SHELL WERE WELL POSITIONED AND REMAINED INTACT. FOLLOW UP SIX MONTHS POST-REVISION DEMONSTRATED FULL RECOVERY WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Inflammation; Metal Related Pathology; Necrosis; Pain; Subluxation; Swelling/ Edema

  MAUDE report 23356500 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493222 ↗
• InjuryNov 25, 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

  MAUDE report 20770960 ↗
• InjuryOct 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO A CHIP OF THE CERAMIC HEAD HAS COME OFF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 20364013 ↗
• MalfunctionSep 2, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20117073 ↗
• InjuryJun 26, 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: Ambulation or Postural Difficulties; Pain

  MAUDE report 19612886 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY A YEAR AND FOUR MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY THREE MONTHS POST-OP, BEGAN TO EXPERIENCE LATERAL PAIN. FOUR MONTHS POST-OP, AT A FOLLOW-UP APPOINTMENT, THE PAIN WAS THOUGHT TO BE ATTRIBUTED TROCHANTER BURSITIS AND IT BAND IRRITATION. THE PATIENT WAS INSTRUCTED TO USE ICING TECHNIQUES, TOPICAL CREAMS, AND WAS PRESCRIBED A NONSTEROIDAL ANTI-INFLAMMATORY DRUG AND PHYSICAL THERAPY. AT THE ONE YEAR POST-OPERATIVE, PROGRESSING WITHOUT COMPLICATIONS AND ALL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 18920601 ↗
• InjuryMar 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 18873334 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, TWO YEARS AND FIVE MONTHS POST INITIAL IMPLANTATION, THE PATIENT REPORTED EXPERIENCING A LOT OF PAIN SINCE RECEIVING THE HIP IMPLANTS. THE PATIENT REPORTED EXPERIENCING MUSCLE ATROPHY, EFFUSION, STIFFNESS, ABNORMAL GAIT, DECREASED ROM WITH SEVERE FEMORAL INTERNAL ROTATION, POPPING SENSATION WITH GRINDING, AND DECREASED STABILITY THAT REQUIRED EXTRA PT. PATIENT NOTES THAT FURTHER METAL ALLERGY TESTING IS PENDING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 18835848 ↗
• InjuryMar 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. ONE YEAR AND THREE MONTHS POST IMPLANTATION, THE HEAD AND STEM WERE REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT WITH FAILURE TO OSTEOINTEGRATE. FIVE YEARS AND FIVE MONTHS POST THE FIRST REVISION PROCEDURE, THE PATIENT WAS REVISED FOR A SECOND TIME DUE TO A FRACTURE OF THE REVISION STEM WITH COMPLICATED EXTRACTION VIA EXTENDED TROCHANTERIC OSTEOTOMY. AFTER THE SECOND REVISION, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS REQUIRING CLOSED REDUCTION UNDER ANESTHESIA. A THIRD REVISION WAS PLANNED BUT DELAYED DUE TO DIFFICULTY EXTUBATING THE PATIENT AND THE CONCURRENT ONSET BILATERAL PULMONARY EMBOLISMS. AFTER THE PATIENT¿S PULMONARY FUNCTION AND ANTICOAGULATION MEASURES WERE STABILIZED, THE REVISION OCCURRED DURING WHICH, MULTIPLE HEMATOMAS WERE EVACUATED FROM THE JOINT, AND POSTERIOR INSTABILITY WAS CONFIRMED ON EXAM. UPON REPLACING THE ACETABULAR SHELL, ANTEVERSION WAS INCREASED BY 15 DEGREES. A NEW CONSTRAINED HEAD AND LINER WERE PLACED WITHIN THE SHELL, AND THE REVISION STEM WAS RETAINED. POSTOPERATIVELY, THE PATIENT DEMONSTRATED SLOW BUT STEADY PROGRESS WITH INTENSIVE PHYSICAL THERAPY. NO FURT

  Patient problems: Hematoma; Joint Dislocation; Pain; Pulmonary Embolism; Respiratory Failure

  MAUDE report 18835517 ↗
• InjuryDec 18, 2023Adverse 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: Bone Fracture(s); Osteopenia/ Osteoporosis; Pain

  MAUDE report 18343178 ↗
• InjuryAug 28, 2023Adverse 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: Unspecified Infection

  MAUDE report 17631261 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT STATED HAVING SHARP PAIN MID-THIGH WHEN STANDING AND WALKING EIGHT MONTHS POST IMPLANTATION. THE PAIN WAS REPORTED TO BE RESOLVED WITHOUT MEDICAL INTERVENTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 17570996 ↗
• InjuryJul 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 17259004 ↗
• InjuryJun 27, 2023Fracture; Fracture

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED BECAUSE THE EVENT IS A DUPLICATE OF A PREVIOUSLY REPORTED INCIDENT. THIS EVENT HAS PREVIOUSLY BEEN REPORTED UNDER MFR REPORT NUMBER 3002806535-2022-00512. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

  Patient problems: Failure of Implant

  MAUDE report 17207345 ↗
• InjuryJun 23, 2023Device 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

  MAUDE report 17188892 ↗
• InjuryApr 11, 2023Adverse 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: Bacterial Infection

  MAUDE report 16711533 ↗
• InjuryDec 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION DUE TO CERAMIC HEAD FRACTURE, 2 WEEKS POST OP. 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 16003243 ↗
• InjuryDec 12, 2022Adverse 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 DEVELOPED AN INFECTION FOR UNKNOWN REASONS. THE INFECTED AREA WAS FLUSHED WITH ANTIBIOTICS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 15957905 ↗
• InjuryJun 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS BENDING AND TWISTING AND FELT A POP AND INCREASED PAIN ON LEFT HIP APPROXIMATELY 1,5 MONTH AFTER INITIAL LEFT HIP PROCEDURE. ANTERIOR DISLOCATION WAS CONFIRMED; PATIENT UNDERWENT A REDUCTION UNDER ANESTHESIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 14631121 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: THE PATIENT WENT TO HAVE HER HIP X-RAYS DONE POST-OP. AS SHE WAS GETTING INTO POSITION FOR HER X-RAY SHE FELT A 'CRUNCH' AND THEN EXCRUCIATING PAIN. THE X-RAY SHOWS THE CERAMIC HEAD BROKEN INTO 3 PIECES. SURGERY IS NEEDED TO REMOVE BROKEN AND AFFECTED IMPLANTS. NEW IMPLANTS PUT IN. PATIENT OUTCOME: REVISION.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13665735 ↗
• InjuryMar 3, 2022Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED, THAT: THE PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022, DUE TO UNDERSIZED IMPLANT, LOOSENING, AND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13658216 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT: THE PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND WAS HOSPITALIZED OVERNIGHT, TREATED MEDICALLY AND RESOLVED ON (B)(6) 2022. COMPONENTS REMAINED IMPLANTED. PATIENT OUTCOME: SERIOUS INJURY.

  Patient problems: Embolism/Embolus

  MAUDE report 13577476 ↗