BIOLOX deltaRecalls & reported problems across all models

We found 11 models of BIOLOX delta by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2017 and Jan 14, 2026 — classified as 1 death, 46 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BIOLOX delta problems

BIOLOX delta models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BIOLOX delta 76539165

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  14 reports
• BIOLOX delta 76539160

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  11 reports
• BIOLOX delta 76539166

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 death9 reports
• BIOLOX delta 71325172

  Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
  3 reports
• BIOLOX delta 76539161

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• BIOLOX delta 76539167

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  3 reports
• BIOLOX delta 71346004

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  2 reports
• BIOLOX delta 71325152

  Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
  1 report
• BIOLOX delta 71325154

  Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
  1 report
• BIOLOX delta 71325174

  Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
  1 report
• BIOLOX delta 76539162

  Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
  1 report

Recent BIOLOX delta adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, PATIENT EXPERIENCED AN UNSPECIFIC ADVERSE EVENT. THEY DID A WASHOUT. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, DURING WHICH, THE BIOLOX DELTA HEAD 32 MM 12/14 M / +4 & R3 36MM ID INTL DLT CER LNR 52MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Medical device site infection

  MAUDE report 24068060 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HIS RIGHT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2020 DUE TO PERIPROSTHETIC JOINT INFECTION, AND RIGHT TOTAL HIP ARTHROPLASTY WITH MULTIPLE DISLOCATIONS. DURING THE REVISION SURGERY, THE WHOLE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR SHELL WITH A REDAPT STEM. AS REPORTED, ON (B)(6) 2020, THE PATIENT SUFFERED FROM INSTABILITY FOLLOWING RIGHT REVISION THA AND PERIPROSTHETIC JOINT INFECTION AND WAS REVISED AGAIN. DURING THIS SECOND REVISION SURGERY, THE FEMORAL HEAD, AND THE ACETABULAR LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 20203020 ↗
• MalfunctionAug 31, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A THR, THE INNER STERILE PACKAGING OF A R3 US DELTA HEAD 32 +4 WAS SHATTERED. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20114263 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY AN INTERVENTION ON (B)(6) 2023, IN WHICH A DAIR (DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) PROCEDURE WAS PERFORMED WITH THE EXCHANGE OF THE R3 36MM ID INTL DLT CER LNR 54MM AND THE DELTA HEAD 36MM 12/14 SHORT +0MM. PATIENT'S HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 17851679 ↗
• InjuryJun 13, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A THR, IT WAS NOTICED THAT THE R3 US DELTA HEAD 32 +4 WAS IMPLANTED WITH A 36 LINER, WHICH IS A SIZE MISMATCH. PATIENT IS SCHEDULED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121824 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2019 WITH LOOSENING - OF THE SOCKET AND LYSIS OF THE SOCKET DIAGNOSIS, THE PATIENT EXPERIENCED DISLOCATION/SUBLUXATION THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2019. ACCORDING TO THE REPORT CONTENTS, THE FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD AND ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A COMPETITORS DEVICE. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A FIRST THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM FEMORAL PROSTHESIS AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Subluxation

  MAUDE report 16286919 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR WAS PERFORMED ON (B)(6) 2013 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED WITH A SMITH AND NEPHEW BEARING COMBINATION. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16051606 ↗
• DeathApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL THR SURGERY PERFORMED (ONLY ONE IS FROM SMITH AND NEPHEW) ON (B)(6) 2010, THE CLINICAL SUBJECT PASSED AWAY ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE AT THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 14103405 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SQUEAKING AND PAIN. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE BIOLOX DELTA HEAD 36 MM 12/14 S / +0 AS THE SURGEON FELT THERE WAS TOO MUCH ANTEVERSION. THE STRIPE WEAR ON HEAD WAS IN A SUPERIOR POSTERIOR POSITION. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13407268 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2021 VIA POSTERIOR APPROACH WITH ANTHOLOGY/R3 CONC CONSTRUCT, THE PATIENT HAD DISLOCATED HIP AT REHAB POST-OP. THE PATIENT HAD A REVISION LEFT THR SURGERY ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE COMPONENTS SEEMED WELL FIXED AND IN APPROPRIATE POSITION BY SURGEON. THE PATIENT WAS DISLOCATING DURING FLEXION AND IR DURING ROM TEST. THE BIOLOX DELTA HEAD 36 MM 12/14 S / +0 WAS REMOVED WITH PUNCH AND THE R3 36MM ID INTL DLT CER LNR 58MM WAS REMOVED WITH A LINER REMOVAL TOOL. THE PATIENT WAS TRIALED WITH 36MM HEADS AND 36X58/20 DEGREE LINER TRIALS AND THE HIP SEEMED STABLE IN ROM. 20 DEGREE XLPE LINER INSERTED AND IMPACTED INTO R3 SHELL, AND 36MM L BIOLOX OPTION HEAD IMPACTED TO RETAINED ANTHOLOGY STEM. THE HIP WAS STABLE THROUGH ROM. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 13111591 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, TWO WEEKS AFTER A REVISION THR SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED PUS FROM THE WOUND. THE INFECTION WAS SOLVED VIA TWO-STAGE REVISION SURGERY, WHOSE FIRST LEG TOOK PLACE ON (B)(6) 2021. IMPLANTS WERE REMOVED WITHOUT ISSUE AND A CEMENT SPACER WAS IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Purulent Discharge

  MAUDE report 12829753 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2018, THE PATIENT PRESENTED TO HOSPITAL WITH A SIGNIFICANT INFECTION AND AN ABSCESS OF HIS RIGHT HIP EXTENDING DISTALLY TO APPROXIMATELY 10CM PROXIMAL TO THE KNEE. THIS ADVERSE SITUATION WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2021, WHERE THE REDAPT 300MM SLEEVED REVISION STEM SIZE 13 HIGH OFFSET, THE REDAPT MODULAR SLEEVE MEDIUM SIZE 12-13 STIKTITE WITH HYDROXYAPATITE AND THE BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8 WERE REMOVED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12537718 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021, TO WASH OUT AND REPLACE THE BIOLOX DELTA HEAD 36 MM 12/14 M / +4 AND A COMPETITOR BRAND LINER. CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12329300 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO DO INCISION AND DRAINAGE AND EXCESSIVE IRRIGATION WAS DONE. THE SURGEON DECIDED TO CHANGE THE R3 US DELTA HEAD 36 +0 TO STOP THE PROGRESSION OF THE INFECTION AND AVOID FURTHER REMOVAL OF ALL THE ORIGINAL TOTAL HIP IMPLANTS, EVEN THOUGH THIS CHANGE IS NOT RECOMMENDED BY SURGICAL TECHNIQUE. HEALTH STATUS OF PATIENT IS NORMAL.

  Patient problems: Unspecified Infection

  MAUDE report 12129265 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 DUE TO A FEMORAL STEM SUBSIDED. IT WAS REPLACED WITH A BIGGER IMPLANT. IMPLANTS REMOVED WERE R3 US DELTA HEAD 32 +4 AND POLARSTEM COLLAR STD. TI/HA 2. THERE ARE NO THOUGHTS FROM THE SURGEON THAT THE IMPLANT FAILED. HE BELIEVES IT WAS UNDERSIZED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 11478943 ↗

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