Biolox 6570-0-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540608468), received between Mar 24, 2017 and Aug 31, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Unstable” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2024Unstable; Unstable

  LEFT HIP REVISED DUE TO INSTABILITY. WE CEMENTED IN AN ALL POLY LINER INTO THE EXISTING COMPETITOR CUP. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Joint Laxity

  MAUDE report 20114744 ↗
• InjuryMay 9, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY AND JOINT LAXITY. AN MDM METAL LINER, ADM/ MDM POLY INSERT, AND 28 -4 FEMORAL HEAD WERE REVISED TO ANOTHER MDM METAL LINER, ADM/ MDM POLY INSERT, AND 28 +4 FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 16898761 ↗
• InjuryJul 7, 2022Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  AS REPORTED VIA THE CONTACT US EMAIL FORM: IN (B)(6) 2018 I HAD BILATERAL TOTAL HIP REPLACEMENT WITH THE STRYKER TRIDENT PSL. IN APPROXIMATELY (B)(6) 2018 I STARTED EXPERIENCING SYMPTOMS IN MY RIGHT HIP. AT THE END OF (B)(6) X-RAYS CONFIRMED MECHANICAL FAILURE OF THE RIGHT HIP JOINT. I AM SCHEDULED FOR REVISION SURGERY ON (B)(6). I AM AWARE OF PAST STRYKER HIP RECALLS. WAS THIS PRODUCT RECALLED? DO YOU HAVE A CLAIMS PROCESS RELATED TO THE TYPE OF PRODUCT LIABILITY? UPDATE (B)(6) 2022 WG: AS REPORTED IN MEDWATCH MW5109954: I WAS IN A DEEP SQUAT AND MY HIP REPLACEMENT FAILED AND SLIPPED OUT. I HAD A BILATERAL HIP REPLACEMENT WITH STRYKER TRIDENT PSL ON 2018. MY RIGHT HIP FAILED ABOUT 3-5 MONTHS LATER CAUSE UNKNOWN, RIGHT REVISION ON 2019. LEFT HIP FAILURE FROM A DEEP SQUAT WITH THE LEFT HIP REVISION SURGERY ON 2022. ADDITIONAL INFORMATION REPORTED: PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 14952193 ↗
• InjuryJun 20, 2022Unstable; Unstable

  PATIENT HAD A BILATERAL STRYKER HIP REPLACEMENT ON (B)(6) 2018 WITH TRIDENT PRODUCT. IN (B)(6) 2018, PATIENT NOTICED INSTABILITY IN RIGHT HIP. PATIENT WAS REVISED IN (B)(6) 2019 DUE TO BROKEN POLY LINER. PATIENT MENTIONED "METAL ON METAL" AND ALLEGES HIGH LEVELS OF CHROMIUM AND COBALT.

  Patient problems: Joint Laxity

  MAUDE report 14750391 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT ALLEGEDLY HAD SUFFERED INJURIES/COMPLICATIONS FROM A FAILED HIP REPLACEMENT PART. UPDATE BASED ON MED REVIEW: RIGHT TOTAL HIP REPLACEMENT REVISION WITH FEMORAL CERAMIC HEAD EXCHANGE WITH A SLEEVE, AS WELL AS ACETABULAR COMPONENT REVISION" FOR A DIAGNOSIS OF "FAILED LINER WITH PARTIAL DISLOCATION OF RIGHT TOTAL HIP AND METALOSIS". THE OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND A POSTERIOR APPROACH. THE REPORT NOTES, " LARGE AMOUNT OF HETEROTOPIC BONE POSTERIORLY, EVENTUALLY, ABLE TO DISLOCATE FEMORAL HEAD, REMOVED CERAMIC HEAD, LINER HAD BEEN DISPLACED ANTERIORLY AND DISLOCATED. THIS HAD LED TO METALOSIS, SIGNIFICANT WEAR ON THE CERAMIC HEAD ONTO THE METAL EDGE, POLYETHYLENE DUAL MOBILITY LINER WAS REMOVED WITH SOME EFFORT. METALLIC SLEEVE HAD SOME SCRATCHES. THE RIGHT HIP DEMONSTRATES THREE SCREWS IN THE ACETABULUM, A RESTORATION MODULAR STEM WHICH APPEARS SUBSIDED, AND A SMALLER MODULAR HEAD WHICH APPEARS TO BE SUPERIORLY MIGRATED IN AN MDM LINER.

  Patient problems: Inflammation; Joint Dislocation; Pain

  MAUDE report 12141303 ↗
• InjuryAug 29, 2019Device Difficult to Setup or Prepare; Fitting Problem; Device Difficult to Setup or Prepare; Fitting Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT AFTER ASSEMBLY, THE 28 -4 BIOLOX HEAD WOULD NOT ARTICULATE FREELY WITH THE UHR BIPOLAR COMPONENT. THE DEVICES WERE WASTED AND A 28 -4 LFIT HEAD WITH A COMPETITOR BIPOLAR COMPONENT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES. A USAGE SHEET SHOWING THE WASTED IMPLANTS WAS SUPPLIED, AND THE DEVICES ARE AVAILABLE FOR RETURN, BUT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON PER THE REPORTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946786 ↗
• InjuryMay 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO THE CERAMIC HEAD BEING FRACTURED. ADDITIONALLY, THE POLY INSERT WAS FOUND TO BE DAMAGED INSIDE. THE 48G ADM/MDM INSERT AND 28 -4 BIOLOX DELTA HEAD WERE REVISED AND THE PATIENT IRRIGATED TO ENSURE ALL PIECES WERE REMOVED. PATIENT WAS REVISED TO A 28 -4 METAL HEAD AND 48G ADM/MDM INSERT. REP PROVIDED A PRE-REVISION X-RAY, PRIMARY AND REVISION IMPLANT SHEETS, AND A PICTURE OF THE EXPLANTS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8603250 ↗
• InjuryDec 18, 2018Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT PATIENT HAS EXPERIENCED AUDIBLE NOISE IN THEIR RIGHT HIP SINCE IMPLANTATION (NOISE REPORTED AS BEING SQUEAKY). AT FIRST, THE NOISE WAS INTERMITTENT, BUT HAS INCREASED IN FREQUENCY AND HAS BECOME MORE PRONOUNCED IN THE LAST 6 MONTHS. THE SURGEON WANTS TO KNOW IF SIMILAR REPORTS HAVE BEEN RECEIVED FOR THESE DEVICES AS THE SURGEON CANNOT DETERMINE IF THE SQUEAKING ARISES FROM THE HEAD/TRUNION INTERFACE OR THE SHELL/LINER INTERFACE. THE PATIENT HAS NOT YET BEEN REVISED, SURGEON WANTS TO WAIT FOR THE AFOREMENTIONED RESULTS BEFORE MAKING A DECISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174696 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED. A COMPETITOR LINER AND STRYKER HEAD WERE EXCHANGED. PATIENT WAS REVISED BECAUSE OF AN ISSUE WITH THE COMPETITOR LINER. THE FEMORAL HEAD HAD TO BE REMOVED FOR ACCESS TO THE ACETABULUM.

  Patient problems: Injury

  MAUDE report 7495623 ↗
• InjuryMar 24, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SALES REP REPORTED A LEFT HIP REVISION SURGERY. PATIENT DISLOCATED THEIR LEFT HIP AND REQUIRED REVISION TO EXCHANGE FEMORAL HEAD AND REDUCTION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6432805 ↗