OXINIUM 71343604Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 03596010477286), received between Mar 31, 2017 and Jan 15, 2026 — classified as 50 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).

4 other recalls cover devices cleared under the same FDA submission (K022958, K024340, K030766, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2023, PATIENT'S HIP DISLODGED AS IT POPPED OUT OF POCKET. PATIENT VISITED THE HOSPITAL, AND THE DEVICE WAS PUSHED BACK INTO POCKET. LATER, THE SAME INCIDENT HAPPENED WHERE THE HIP DISLODGED AGAIN AND WAS PUSHED BACK INTO POCKET. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, DURING WHICH, THE OXINIUM FEM HD 12/14 36 MM M/+4 AND R3 0 DEG XLPE ACET LNR 36MM X MM56 WERE EXCHANGED. PATIENT'S CURRENT HEALTH CONDITION IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 24077633 ↗
• InjuryOct 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED SEVERAL DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A OXINIUM FEM HD 12/14 36 MM M/+4 AND A R3 20 DEG XLPE ACET LNR 36MM X 52MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20435530 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY ON AN UNSPECIFIED DATE, THE OXINIUM FEM HD 12/14 36 MM M/+4 WAS EXPLANTED ON AN UNSPECIFIED DATE FOR UNKNOWN REASONS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735299 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT PRESENTED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN WHICH AN OXINIUM HEAD AND A COMPETITOR'S LINER WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19660305 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR, A REVISION SURGERY WAS PERFORMED, IN WHICH A OXINIUM FEM HD 12/14 36 MM M/+4 WAS EXCHANGED WITH A OXINIUM FEM HD 12/14 36 MM M/+12 BECAUSE THE PATIENT HAD A FRACTURE, CAUSING STEM TO SUBSIDE, THIS CAUSED A SHORTENED LEG SO IT WAS NEEDED TO ADD LENGTH. ALSO A R3 0 DEG XLPE ACET LNR 36MM X 52MM WAS EXCHANGED BECAUSE THE SURGEON DECIDED TO FOLLOW A POSTERIOR APPROACH, THERE WAS NO LINER FAILURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture; Unequal Limb Length

  MAUDE report 18387424 ↗
• InjurySep 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR A PATIENT DISLOCATED DUE TO UNKNOWN REASONS. THEREFORE THE OXINIUM FEM HD 12/14 36 MM M/+4 AND R3 20 DEG XLPE ACET LNR 36MM X 60MM WERE REPLACED. IMPLANTS WERE REMOVED WITH NO COMPLICATIONS, AND TRIAL REDUCTION AND ROM WAS SUCCESSFUL. DURING THE PROCEDURE, OSTEOLYSIS WAS ALSO FOUND AROUND THE PROXIMAL FEMORAL STEM, BUT THE STEM WAS WELL INTACT. THERE WAS NO TAPER CORROSION, HEAD SCRATCH OR POLY WEAR. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation; Osteolysis

  MAUDE report 17680467 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT THR REVISION SURGERY (B)(6) 2016 DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, THE PATIENT EXPERIENCED ANOTHER ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, ALL THE FEMORAL HEAD, ACETABULAR CUP AND ACETABULAR LINER WERE EXPLANTED. 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: Foreign Body In Patient

  MAUDE report 16285898 ↗
• InjuryDec 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER LEFT THR WAS PERFORMED ON (B)(6) 2021 DUE TO SKELETAL DYSPLASIA, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL 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 16048334 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2018 TO ADDRESS A DIAGNOSIS OF ADVANCED DEGENERATION OF THE HIP JOINT, THE PATIENT SUFFERED AN INFECTION POSITIVE FOR MSSA ALONG WITH AN HEMATOMA AND REQUIRED A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, AN INCISION AND DRAINAGE WAS PERFORMED WITH AN EXCHANGE OF THE FEMORAL HEAD AND ACETABULAR LINER. FURTHER INFORMATION IS NOT KNOWN.

  Patient problems: Bacterial Infection; Hematoma; Medical device site infection

  MAUDE report 15579943 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR PERFORMED ON (B)(6) 2022, THE PATIENT HAD AN INFECTION. A REVISION SURGERY WAS ADDRESSED TO EXPLANT ALL THE IMPLANTS (OXONIUM FEM HD 12/14 32 MM +4, R3 20 DEG XLPE ACET LNR 36 MM X 52 MM, R3 0 HOLE HA CTD ACET SHELL 52 MM, REF INTERFIT THRD HOLE COVER AND POLARSTEM STEM LAT.TI/HA 1 NON-CEM) AND INSERT CEMENT SPACERS. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 15257852 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGED THE OXINIUM FEM HD 12/14 36 MM M/+4 ON THE RIGHT SIDE. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14861402 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY THR SURGERY PERFORMED ON THE (B)(6) 2021, THE PATIENT WENT FOR A CLINIC FOLLOW UP AND COMPLAINED HER OPERATIVE LEG FELT SHORT. FOLLOWING RADIOGRAPHIC AND PHYSICAL EXAMINATION, THE SURGEON DECIDED TO PERFORM A REVISION SURGERY AND, ON THE (B)(6) 2022, THE OXONIUM FEM HD 12/14 36 MM M/+4 WAS EXPLANTED AND REPLACED WITH +12 HEAD TO INCREASE THE LEG LENGTH. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unequal Limb Length

  MAUDE report 13694258 ↗
• InjuryFeb 24, 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 (B)(6) 2022 THE PATIENT EXPERIENCED DISLOCATION DUE TO THE COMPONENTS BEING PLACED IN A SUB-OPTIMAL POSITION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY TO EXPLANT THE COMPLETE SYSTEM ON (B)(6) 2022. THE PHYSICIAN REVISED AN OXINIUM FEM HD 12/14 36 MM M/+4. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13591688 ↗
• InjuryDec 9, 2021Biocompatibility; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2016 DUE TO END-STAGE DEGENERATIVE JOINT DISEASE OF BOTH HIPS WITH VASCULAR NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO A COMPLICATED POSTOPERATIVE COURSE, CHROMIUM AND COBALT LEVELS ON THE IMPLANTS REFLECTED INCREASING COBALT LEVELS IN THE 15-16 RANGE COMBINED WITH FLUID AND INCREASING/PERSISTENT PAIN. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 12966801 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY WAS PERFORMED IN THE PATIENT¿S RIGHT HIP ON (B)(6) 2021 (REVISION SURGERY COVERED UNDER CASE-(B)(4)), THE PATIENT DEVELOPED A SURGICAL SITE INFECTION. THE ADVERSE EVENT WAS TREATED VIA A SECOND REVISION SURGERY AND AN I&D PROCESS, IN WHICH THE FEMORAL HEAD AND THE LINER WERE EXPLANTED. THE OUTCOME OF THE PATIENT WAS NOT REPORTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12804884 ↗
• MalfunctionNov 3, 2021Break

  IT WAS REPORTED THAT AFTER VISUAL INSPECTION OF THE DEVICE MI TRIAL FEM HEAD 36 +8 IT WAS CONFIRMED THAT ONE OF THE TABS BROKE OFF THE DEVICE, RENDERING IT INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746169 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR THAT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED LEAKING OF THE WOUND DUE TO STAPHYLOCOCCUS INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. THE SURGEON PERFORMED AN INCISION THROUGH THE PREVIOUS INCISION, WASHED THE HIP OUT AND TOOK PATHOLOGY SAMPLES. THE INITIAL PLAN WAS TO PERFORM A FEMORAL HEAD AND LINER EXCHANGE BUT WHEN THE SURGEON WAS USING A PUNCH TO GET THE FEMORAL HEAD OFF, IT KNOCKED THE FEMORAL STEM LOOSE. SO THE SURGEON NEEDED TO REPLACE THE STEM ALSO. NEW SN DEVICES WERE IMPLANTED. THE CURRENT STATUS OF PATIENT¿S HEALTH IS UNKNOWN. NEW IMPLANTS THAT WERE PUT IN: 71332754 LOT #20KM04471 ACETABULAR LINER, 71357107 LOT #20KM05452 ANTHOLOGY FEMORAL COMPONENT, 71343604 LOT #20MM11041.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 11648432 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL THA PERFORMED ON (B)(6) 2021, THE PATIENT SUFFERED FROM A DISLOCATION ON (B)(6) 2021. MANUAL REPOSITIONING WAS PERFORMED. THE CAUSAL RELATIONSHIP AND SEVERITY HAVE NOT BEEN DETERMINED AS OF TODAY.

  Patient problems: Joint Dislocation

  MAUDE report 11593542 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR THAT HAD BEEN PERFORMED ON 2019, THE PATIENT EXPERIENCED A DISLOCATION WHILE SQUATTING DOWN AND LEANING TO HIS FAR RIGHT TO REACH FOR POWER SOCKET. THEN, CONTINUED TO EXPERIENCE SUBSEQUENT DISLOCATIONS. PATIENT UNDERWENT REVISION SURGERY TO REMOVE 20 DEG XLPE ACET LNR ((B)(4)) AND OXINIUM FEM HD ((B)(4)) AND REPLACE WITH CONSTRAINED LINER AND NEW FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 11449959 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT WAS DISLOCATING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXCHANGE THE FEMORAL HEAD. THE STEM WAS LEFT IN SITU. THE ACETABULAR COMPONENTS WERE FROM ZIMMER. THE SURGEON WAS PLEASED WITH THE OUTCOME.

  Patient problems: Joint Dislocation

  MAUDE report 11155211 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE ACETABULAR LINER WAS REMOVED AND REPLACED ON (B)(6) 2020. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10979967 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY SURGERY (THR), DURING THIS SURGERY A LINER, ONE OXINIUM HEAD, 3 SCREWS, AND ONE STEM WERE IMPLANTED. 6 WEEKS POST-OPERATIVE, THE PATIENT PRESENTED A DISLOCATION OF THE THR, FEELING A SLIPPING SENSATION IN CERTAIN POSITIONS. AFTER THAT, A MUA/REVISION OF RIGHT THR WAS PERFORMED. THE SURGEON DID A REVISED THROUGH THE DAA APPROACH AND THE HEAD AND LINER WERE REMOVED AND A NEW LINER AND NEW HEAD WERE IMPLANTED. ADDITIONALLY, IT WAS INSERTED A HOOD OF A LINER POSITIONED LATERALLY FOR EXTRA COVERAGE. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS AS PER THE TECHNIQUE. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10604062 ↗
• InjuryJun 18, 2020Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE LEFT HIP DUE TO FAIL THA, WITH GROSSLY LOOSE AND UNSTABLE FEMORAL COMPONENT. SINCE PRE-OPERATIVELY, THA WAS DIAGNOSED FAILED AND AFTERWARDS, INTRAOPERATIVELY, THE STEM WAS NOTICED LOOSE AND THE CUP WAS REMOVED, IT CANNOT BE DISCARDED THE INCIDENCE OF THE REMOVED COMPONENTS TO THE THA FAILURE.

  Patient problems: Injury; Joint Disorder

  MAUDE report 10166252 ↗
• InjuryJun 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN EXCELLENT RECOVERY FROM THE PRIMARY SURGERY ((B)(6) 2020), BUT ABOUT FOUR WEEKS AGO, DEVELOPED A WOUND OOZE WHICH DID NOT IMPROVE WITH WOUND CARE AND ANTIBIOTICS, SO A WASHOUT WAS PERFORMED ((B)(6) 2020). THE PATHOLOGY REVEALED THAT IT WAS PSEUDOMONAS AND STAPHYLOCOCCUS. THEREFORE, A REVISION SURGERY, WASHOUT AND DEBRIDEMENT WAS PERFORMED VIA THE PREVIOUS INCISION. THE HEAD WAS REMOVED. SURGEON STATED THAT THE HIP WAS STABLE AND THAT THE PATIENT HEALTH WAS SATISFACTORY.

  Patient problems: Unspecified Infection

  MAUDE report 10109048 ↗
• InjuryMay 4, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAS ALZHEIMER¿S AND DOES NOT COMPLY WITH MOVEMENT RESTRICTIONS FOR THA. SHE CONTINUOUSLY DISLOCATES AND THE SURGEON DECIDED TO REVISE TO A CONSTRAINED LINER. NO MEDICAL RECORDS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 10022622 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022958, K024340, K030766, 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.
• Z-1901-2024 · Apr 24, 2024 · Open, Classified
  smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
• Z-0389-2010 · Jan 23, 2009 · Terminated
  Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
• Z-2314-2009 · Jan 12, 2009 · Terminated
  Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.