BIOLOX DELTA 1365-28-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295033240), received between Feb 8, 2018 and Jul 8, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED OUT OF THEIR CONTRAINED LINER DUE TO WEAR. DOCTOR DECIDED TO DO A LINER AND HEAD EXCHANGE AFTER WASHING OUT THE HIP. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 25747100 ↗
• InjuryApr 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL HIP DONE WITH A SROM STEM AND SROM CUP PLACED AROUND THIRTY YEARS AGO. PATIENT DEVELOPED POLY WEAR, SO PATIENT HAD A HEAD AND LINER EXCHANGE DONE ON (B)(6) 2019. WAS DOING GREAT UNTIL RECENTLY; THE PATIENT FELL AND DISLOCATED. THE SURGEON WANTED TO REMOVE THE CUP. DID A COMPLETE ACETABULAR REVISION UTILIZING DUAL MOBILITY KEEPING THE SROM HEAD IN PLACE. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 24790752 ↗
• InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC DISLOCATIONS. DOI: (B)(6) 2020 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23318550 ↗
• InjuryOct 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT CAME IN AFTER DISLOCATING TWICE IN A WEEK. DR DECIDED IT BEST TO REMOVED THE CUP, LINER, HEAD AND STEM TO CHANGE THE ORIENTATION OF THE IMPLANT TO BE MORE STABLE. HE PLACED A NEW 16X11 +6 STEM AND A 28 +6 HEAD INTO A ZIMMER CUP/DUAL MOBILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO MORE PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20452902 ↗
• InjuryApr 11, 2023Fracture; Noise, Audible; Fracture; Noise, Audible

  THE PATIENT PRESENTED WITH A HIP THAT WAS MAKING A GRINDING NOISE THAT HAD BEEN ONGOING FOR 3 MONTHS. HE HAD A PREVIOUS HIP SURGERY 9 YEARS AGO. UPON X-RAY, IT WAS DETERMINED THAT THE DELTA CERAMIC SROM HEAD HAD FRACTURED INTO 3 PIECES. THE SURGEON REMOVED THE HEAD AND LINER THAT HAD WORN THROUGH BY THE "TRUNNION" OF THE SROM STEM. HE REPLACED WITH A METAL HEAD AND NEW ALTRX LINER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16712356 ↗
• InjuryMar 21, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PATIENT UNDERWENT A LEFT HIP FIRST REVISION ON (B)(6) 2021 (B)(4) WHERE A CONSTRAINED POLY LINER AND CERAMIC HEAD WERE PLACED. ON (B)(6) 2022, THE PATIENT UNDERWENT A HEAD AND LINER REVISION SECONDARY TO SUSTAINING AN ANTERIOR DISLOCATION. INTRAOPERATIVELY, A HEMATOMA WAS EVACUATED. RESIDUAL METAL DEBRIS WAS IDENTIFIED. THE LINER DEMONSTRATED POLYWEAR. THERE WAS EVIDENCE OF WEAR OF THE CERAMIC HEAD FROM WHERE THE HEAD HAD DISLOCATED CAUSING ABRASION AND LOSS OF THE CERAMIC COATING. DOI: (B)(6) 2021; DOR: (B)(6) 2022; LEFT HIP SECOND REVISION.

  Patient problems: Erythema; Hematoma; Itching Sensation; Joint Dislocation; Pain

  MAUDE report 16581747 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15894015 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY THR WHERE A COMPETITOR FEMORAL COMPONENT AND A COMPETITOR ACETABULAR COMPONENT WAS UTILISED (DR. (B)(6), DATE UNKNOWN). PATIENT PRESENTED WITH PAIN AND THE COMPONENTS WERE REMOVED AND A TEMPORARY "KIWI" SPACER IMPLANTED - COMPETITOR STEM AND CUP (DR. (B)(6), DATE UNKNOWN) PATIENT WAS RETURNED FOR THE SECOND OF THE TWO STAGE PROCEDURE WHERE A COMPETITOR ACETABULAR SHELL WITH DUAL MOBILITY AND AN SROM STEM WAS UTILISED ((B)(6) 2022). PATIENT HAS PRESENTED WITH ONGOING PAIN AND A DECISION WAS MADE TO PERFORM A WASHOUT WITH LINER EXCHANGE AND A HEAD EXCHANGE ((B)(6) 2022). NO OBVIOUS SIGNS OF INFECTION WERE EVIDENT. UNSURE WHETHER ANY ORGANISMS HAVE BEEN CULTURED. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, IF YES, PLEASE DESCRIBE. POSSIBLE INFECTION - BUT THIS SUSPECTED AT TIME OF S ROM STEM IMPLANTATION AS THIS WAS THE SECOND OF A TWO STAGE PROCEDURE, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6) HOS

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15067068 ↗
• InjuryMar 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13950589 ↗
• InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT SHOWED UP IN ER AT AN OUTSIDE FACILITY AFTER DISLOCATING HER HIP. PATIENT WAS TRANSFERRED TO OPERATING SURGEON AS ON CALL SURGEON WAS UNABLE TO RELOCATE. COMPONENTS WELL FIXED AND WELL POSITIONED. HEAD AND LINER EXCHANGE PERFORMED WITH A 10 DEGREE LINER SHOWING EXCELLENT STABILITY. NO WEAR WAS NOR IMPINGEMENT WAS NOTED ON LINER. DOI: (B)(6) 2016 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 11891690 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10819060 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10786673 ↗
• InjuryApr 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED HER CONSTRAINED LINER. OLD LINER AND HEAD WERE REMOVED AND A NEW CONSTRAINED LINER AND HEAD WERE IMPLANTED. THE LINER AND RING WERE STILL WELL FIXED AND IN CORRECT POSITION. THE HEAD WAS STILL WELL FIXED TO THE STEM. THE SURGEON HAS SUSPICION THAT THE PATIENT IS VOLUNTARILY DISLOCATING. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SITE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9933293 ↗
• InjuryJul 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN REDUCTION AND ELEVATED METAL IONS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATING RIGHT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2013. DOR: (B)(6) 2014. (RIGHT HIP) 2ND REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8799363 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES DISLOCATIONS, PAIN, WALKING DIFFICULTY AND LIMITED MOBILITY. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS RECURRENT INSTABILITY AND DISLOCATION. REVISION NOTES REPORTED THAT THE DEPUY HEAD WAS RETAINED AND COMPETITOR ACETABULAR COMPONENTS WERE REPLACED. DOI: (B)(6) 2017; DOE: DEC 13, 2017; LEFT HIP.

  Patient problems: Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8748780 ↗
• InjuryApr 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LITIGATION ALLEGES DISLOCATION, DISASSOCIATION, PAIN, MEDICAL DEVICE SITE JOINT MOVEMENT IMPAIRMENT, AND EMOTIONAL DISTRESS. DOI: (B)(6) 2010; DOR: (B)(6) 2015; (RIGHT HIP).

  Patient problems: Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8539962 ↗
• InjuryApr 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH OPEN AND CLOSED REDUCTION. DOI: (B)(6) 2012 - DOR: (B)(6) 2012; (RIGHT HIP). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8470129 ↗
• InjuryFeb 14, 2019Naturally Worn; Naturally Worn

  LITIGATION PAPERS ALLEGE: CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT; SINCE SURGERY, PATIENT HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SWELLING, SORENESS, DIFFICULTY WALKING, DECREASED MOBILITY AND/OR THE NEED FOR REVISION SURGERY. UPDATE: ALTHOUGH LITIGATION REPORTED THIS AS METAL ON METAL, PRODUCT INFORMATION INDICATES THE PATIENT HAD POLY ON METAL. DOI: (B)(6) 2008; DOR: NOT REPORTED; (LEFT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 8340390 ↗
• InjuryFeb 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7250718 ↗