BIOLOX DELTA 1365-32-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295033400), received between Jul 21, 2017 and Feb 4, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24261995 ↗
• InjuryMay 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURED CERAMIC HEAD. NO KNOWN FALL, ETC. LARGE FRAGMENTS RETRIEVED. UNKNOWN QUANTITY OF FRAGMENTS RETAINED. SHELL REVISED TO INCREASE HIP STABILITY. LINER DAMAGE BY HEAD FRACTURE AND TRUNION CONTACT. DOI: (B)(6) 2013. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body In Patient; Joint Laxity

  MAUDE report 22039487 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2013. DOR- (B)(6) 2013. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 16479719 ↗
• InjuryOct 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD THEIR HIP ORIGINALLY DONE SEVERAL YEARS AGO. SURGEON WAS UNSURE OF THE EXACT DATE. PATIENT HAD THEIR FIRST REVISION DONE LAST WEEK ON (B)(6). SURGEON PERFORMED A HEAD AND LINER EXCHANGE. UNFORTUNATELY THE POLY CAME DISENGAGED FROM THE CUP AND THE PATIENT DISLOCATED AGAIN. SURGEON WENT IN TO REVISE AGAIN, AND REALIZED THE INSIDE OF THE PINNACLE CUP WAS DAMAGED FROM THE LINER BECOMING DISENGAGED AND THE FEMORAL HEAD RUBBING ON THE INSIDE OF THE CUP. HE OPTED TO REVISE THE WHOLE ACETABULAR COMPONENT TO A ZIMMER BIOMET CONSTRUCT AND USE THEIR DUAL MOBILITY IMPLANT. A TRIAL REDUCTION WAS PERFORMED WITH OUR 28MM FEMORAL HEAD AND THEIR DM AND FOUND TO BE STABLE. THE REAL 28MM +3 FEMORAL HEAD WAS OPENED AND IMPLANTED. CLOSING PROCESS BEGAN. THERE WAS NO LOOSENING EXPERIENCED AND THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15568753 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION RIGHT TOTAL HIP REPLACEMENT WHERE SEVERAL REVISIONS HAVE OCCURRED. THE ORIGINAL PRIMARY SURGEON IMPLANTED AN ¿ESCA¿ PRIMARY HIP REPLACEMENT WITH A CEMENT MODULAR NECK FEMORAL COMPONENT AND CEMENTLESS ACETABULAR COMPONENT WITH AN ALUMINA CERAMIC ON CERAMIC BEARING APPROXIMATELY 20 YEARS AGO. THE FEMORAL COMPONENT ASEPTICALLY LOOSENED OVER A DECADE AGO AND THE FEMUR REVISED TO AN SROM FEMORAL COMPONENT WITH A CERAMIC HEAD. THE ESCA ACETABULAR COMPONENT WAS NOT CHANGED AT THIS TIME. THIS REVISION SURGERY WAS UNDERTAKEN BY DR PETER. THE SROM FEMORAL COMPONENT (FROM MEMORY AND MY RECOLLECTION) FRACTURED APPROXIMATELY FIVE YEARS OR MORE AGO AND WAS REVISED AND REMOVED BY EXCEPT FOR ONE SEGMENT OF METAL THAT WAS PUSHED DISTAL DOWN THE FEMORAL CANAL, WELL DISTAL OF ANOTHER NEW PRIMARY SROM FEMORAL COMPONENT AND CERAMIC HEAD. THE ACETABULAR COMPONENT (ESCA) REMAINED INSITU WITH THE ALUMINA CERAMIC BEARING. THE REVISION TODAY ENTAILED REVISION FOR INSTABILITY REQUIRING THE CHANGING OF THE FEMORAL HEAD AND REMOVAL OF THE ESCA ALUMINA CERAMIC ACETABULAR BEARING THAT WAS ORIGINAL FROM THE PRIMARY SURGERY. THE REVISION TODAY ESSENTIALLY REQUIRED THE CHANGING OF AN SROM CERAMIC FEMORAL H

  Patient problems: Joint Laxity

  MAUDE report 13928525 ↗
• InjuryMar 10, 2022Fracture; Fracture

  REVISION COMPLETED DUE TO PAIN AND INCREASING STIFFNESS AFTER SUFFERING A FALL. PREOPERATIVE IMAGES INDICATED A FRACTURED FEMORAL HEAD. UPON EXPOSURE, THE FEMORAL HEAD WAS CONFIRMED TO BE FRACTURED. APPROXIMATELY 6 LARGE FRAGMENTS AND 5-7 SMALLER FRAGMENTS WERE RETRIEVED FROM THE ACETABULUM AND SURROUNDING SOFT TISSUE. THE LINER WAS ALSO FOUND TO BE DAMAGED, ALTHOUGH STILL SECURELY LOCKED IN THE SHELL. THE LINER WAS REMOVED AND THE CUP WAS EXAMINED FOR DAMAGE. AFTER BOTH CUP AND TRUNION WERE FOUND TO BE SUITABLE, TRIAL PARTS CONFIRMED THE STABILITY OF THE COMPONENTS AND THE DEFINITIVE IMPLANTS WERE IMPLANTED. THERE WERE NOT ANY UNEXPECTED DELAYS DURING THE PROCEDURE. DOI: (B)(6) 2012; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Muscular Rigidity; Pain

  MAUDE report 13721364 ↗
• InjuryNov 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12769572 ↗
• InjuryMay 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PATIENT HAD HER HIP REPLACED SOME TIME AGO IN THE PAST. EXACT DATE UNKNOWN. SHE RECENTLY DISLOCATED HER HIP SEVERAL TIMES AND IT WAS DECIDED TO REVISE HER HIP CONSTRUCT TO A CONSTRAINED LINER TO HELP PREVENT FURTHER DISLOCATIONS. SURGEON EXPLANTED A 32MM X 48MM NEUTRAL PINNACLE LINER, AND A 32MM + 0 SROM HIP BALL. THE 48MM SECTOR CUP, SROM SLEEVE, AND SROM STEM WERE LEFT IN SITU. UNFORTUNATELY THE LOT NUMBER INFORMATION COULD NOT BE RECORDED UPON EXPLANATION BECAUSE THE NUMBERS WERE ILLEGIBLE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN AFFECTED SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 11841755 ↗
• InjuryApr 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON INFORMED THE SALES CONSULTANT THAT HE HAD PERFORMED THIS PATIENT'S INITIAL SURGERY ABOUT 10-11 YEARS PRIOR, EXACT DATE UNKNOWN. HE WAS UNABLE TO PULL UP THE OPERATIVE NOTE TO GIVE ME AN EXACT DATE. THIS PATIENT SUFFERED A HIP DISLOCATION THAT WAS BELIEVED TO HAVE HAPPENED SEVERAL MONTHS PRIOR. THIS PATIENT SUFFERS FROM CEREBRAL PALSY AND IS A BED BOUND PATIENT. THIS PATIENT ALSO UNFORTUNATELY HAD AN ULCER ON THEIR HIP THAT WENT DOWN INTO THE JOINT SPACE. DR. DECIDED THIS PATIENT'S BEST OPTION WAS UNFORTUNATELY TO REMOVE THE IMPLANTS AND PERFORM A GIRDLESTONE PROCEDURE. ONCE IMPLANTS WERE PROPERLY REMOVED A THOROUGH DEBRIDEMENT WAS PERFORMED OF THEIR HIP AND THE CLOSING PROCESS BEGAN. DOI: 10 TO 11 YEARS PRIOR, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Pressure Sore/Ulcer

  MAUDE report 11675224 ↗
• InjuryApr 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A. CAN YOU PLEASE CLARIFY IF THE FRACTURE WAS ON THE BONE OR ON THE IMPLANT? IF BONE, PLEASE CONFIRM THE LOCATION OF BONE FRACTURE, WAS IT THE ACETABULAR SIDE OR FEMORAL SIDE? ANSWER: FEMORAL BONE.

  Patient problems: Joint Dislocation

  MAUDE report 11632057 ↗
• InjuryFeb 1, 2021Fracture; Fracture

  PATIENT BEING REVISED (B)(6) 2021 DUE TO TRAUMATIC FALL AND THE RESULT IS A FRACTURED CERAMIC FEMORAL HEAD. NO DELAY. INITIAL SURGERY DATE: (B)(6) 2015; RIGHT SIDE.

  Patient problems: Fall

  MAUDE report 11262865 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OP DATE (B)(6) 2020 RIGHT SIDE, (B)(6) HOSPITAL. PATIENT HAD DISLOCATED AND THE SURGEON WANTED TO REPOSITION THE PINNACLE CUP AND LINER. PREVIOUS CUP, CERAMIC LINER AND SCREW REMOVED AND REPLACED WITH NEW CUPS, LINER AND SCREWS.

  Patient problems: Joint Dislocation

  MAUDE report 10984325 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ILIOPSOAS PAIN SO THE CUP WAS REVISED. DOI: (B)(6) 2011, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Pain

  MAUDE report 10927974 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PAINFUL HIP. REMOVED TWO DOME SCREWS AND CHANGED HEAD & LINER. COULDN'T SEE NUMBERS ON THE SCREWS. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2013, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10601839 ↗
• InjuryMar 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9779882 ↗
• InjuryJan 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT WAS HAVING ISSUES WITH DISLOCATION. HE SAID PATIENT HIP WAS ORIGINALLY DONE BY SURGEON ON (B)(6) 2008 AT (B)(6). HE HAD REVISED THE PATIENT ONCE BEFORE FROM A METAL ON METAL CONSTRUCT. THIS FIRST REVISION WAS ON (B)(6) 2019, (CASE #: (B)(6)). A 50 X 32 NEUTRAL LINER WAS REMOVED, AS WELL AS A 32MM +0 FEMORAL HEAD. THE STEM WAS UNABLE TO BE ADJUSTED, SO THE SURGEON OPTED FOR A 50 X 28 +4 10 DEGREE CONSTRAINED LINER WITH A 28 MM +3 FEMORAL HEAD. PATIENT WAS FOUND TO BE STABLE AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2019; DOR: (B)(6) 2020, (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9597053 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) HAS INDICATED THAT AFTER THE REVISION, THE PATIENT HAS NOTED A LEG LENGTH DISCREPANCY AND PAIN. THE MEDICAL RECORDS BELIEVE THE PAIN CAN BE ATTRIBUTED TO POSSIBLE LYMPHOMA. IN ADDITION PPF ALLEGES ELEVATED METAL IONS AFTER 1ST REVISION. DOI: (B)(6) 2014; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Pain

  MAUDE report 9397860 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CODED MEDICAL DEVICE SITE MOVEMENT IMPAIRMENT TO HEAD AND LINER.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Tissue Damage

  MAUDE report 9336223 ↗
• InjuryMay 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DUE TO DISLOCATION, THE SURGEON INCREASED THE HEAD LENGTH. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8658360 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2011; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8603334 ↗
• InjuryApr 1, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INCISION AND DRAINAGE WAS PERFORMED WITH HEAD AND LINER EXCHANGE TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8471201 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED THE PATIENTS TOTAL HIP ON (B)(6) 2019. THE PATIENTS HIP BECAME INFECTED, SO THE SURGEON DECIDED TO WASHOUT THE PATIENTS HIP AND SWAP OUT THE HEAD AND LINER. ONCE WASHOUT WAS COMPLETED, THE DOCTOR IMPLANTED A 50MMX32MM +4 10 DEGREE LINER AND 32MM +0 HEAD. HIP WAS REDUCED AND THE CLOSING PROCESS WAS STARTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8369835 ↗
• InjuryFeb 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEET RECEIVED. PPF ALLEGES DISLOCATION AND ELEVATED METAL IONS AFTER THE FIRST REVISION SURGERY. DOI: (B)(6) 2011 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8357558 ↗
• InjuryJan 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8249055 ↗
• InjuryJan 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 8217209 ↗