BIOLOX delta 76539165Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010566959), received between Sep 18, 2017 and Oct 2, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K083762, K211176); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT SUFFERED FROM DISLOCATION. SURGEON REPLACED THE CERAMIC HEAD WITH AN OXINIUM 28MM AND REPLACE THE EXISTING PINNACLE GRIPTION CUP WITH A CAPTURE CUP.

  Patient problems: Joint Dislocation

  MAUDE report 10754837 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, WHO HAD UNDERGONE A THR IN SITU FROM 2011, RECENTLY FELL AT WORK AND WAS NON-WEIGHT BEARING SINCE. X-RAYS POST-FALL WERE INCONCLUSIVE, AND A PLAN WAS MADE TO REVISE THE HEAD, LINER, AND ALSO THE CUP IF REQUIRED. DURING REVISION SURGERY, IT WAS DETERMINED THAT THE STEM HAD A GOOD FIXATION BUT THE CUP WAS LOOSE. THE R3 3 HOLE ACETABULAR SHELL 56MM, R3 36MM ID US DELTA LINER 54MM OD, BIOLOX DELTA HEAD 36 MM 12/14 S / +0, AND 2 SCREWS WERE REVISED AND 56 MULTIHOLE CUP, 5 SCREWS, 56/36 CERAMIC LINER, 36+0 CERAMIC HEAD WERE IMPLANTED INSTEAD. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10338161 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  *LITERATURE CASE* "MID-TERM CLINICAL RESULTS OF THE CEMENTLESS R3 CUP AND POLARSTEM TOTAL HIP ARTHROPLASTY". AUTHOR: ALI ASSAF ET AL., EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY (2019). IT WAS DOCUMENTED ON THE PAPER THAT ONE PATIENT WAS INITIALLY REVISED OF A HIP RESURFACING (DUROM ZIMMER) DUE TO METAL HYPERSENSITIVITY WITH POST-OPERATIVE CHROMIUM LEVEL OF 1150 NMOL\L TO A PRIMARY R3/POLARSTEM COMBINATION. THE PATIENT FELL AND SUSTAINED AN ANTERIOR DISLOCATION OF THE HIP AT 1 YEAR POST-OPERATIVELY. THIS WAS REDUCED CLOSED, BUT THE PATIENT CONTINUED TO EXPERIENCE WORSENING SQUEAKING AND GROIN PAIN. IT WAS SUBSEQUENTLY REVISED AT 4.5 YEARS FROM INITIAL OPERATION. THE ACETABULAR CUP WAS REVISED TO A 56 MM TRABECULAR METAL SHELL (ZIMMER BIOMET), WITH A 36 MM ACETABULAR XLPE LINER AND 36 MM OXINIUM HEAD.

  Patient problems: Foreign Body Reaction; Inflammation; Pain

  MAUDE report 10236478 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DISLOCATION. THE DOCTOR SAYS THE DEVICES WERE NOT DEFECTIVE BUT THE POSITION TO INSERT SHELL WAS NOT APPROPRIATE.

  Patient problems: Injury

  MAUDE report 9983973 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A BILATERAL PULMONARY EMBOLISM. THE EVENT WAS TREATED WITH MEDICATION THERAPY AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Injury

  MAUDE report 9413647 ↗
• InjurySep 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT HIP REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. PATIENT WAS NOT COMPLIANT WITH POST OPERATIVE INDICATIONS.

  Patient problems: Injury

  MAUDE report 9056874 ↗
• InjuryNov 16, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATION EPISODE WITHOUT ANY INFORMATION OF THE DATE OF OCCURRENCE OR TREATMENT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8077615 ↗
• InjuryNov 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TWO DISLOCATION EPISODES (ONE GETTING OUT OF LOW RECLINER AND THE SECOND BENT OVER WITH LEG FLEXED TO REACH FOOT), A REVISION SURGERY WAS PERFORMED TO CHANGE FEMORAL HEAD AND LINER TO A CONSTRAINED LINER.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8063963 ↗
• InjuryJun 18, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION AFTER FALL.

  Patient problems: Injury

  MAUDE report 7608756 ↗
• InjurySep 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SQUEAKING AND PAIN FROM LEFT HIP.

  Patient problems: Injury; Pain

  MAUDE report 6874402 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083762, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.