OXINIUM 71342200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010488862), received between Dec 21, 2017 and Aug 28, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K021673, K024340, K030766, K211176, K240783); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse 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) 2025, THE PATIENT EXPERIENCED A PROXIMAL FEMUR FRACTURE WHICH WAS FOUND ON AN X-RAY PERFORMED ON (B)(6) 2025, THE NEXT DAY POST-OPERATION. THE REASON FOR THE FRACTURE IS UNKNOWN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) POLARSTEM VALGUS TI/HA 0 , ONE (1) OXINIUM FEM HD 12/14 22 MM +0, AND ONE (1) OR3O DM XLPE INSERT 22/36 WERE EXPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Periprosthetic fracture

  MAUDE report 22910266 ↗
• InjuryApr 30, 2025Adverse 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) 2024, THE PATIENT EXPERIENCED PAIN AND INTRA-PROSTHETIC DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE OXINIUM FEM HD 12/14 22 MM +0, OR3O DUAL MOBILITY LINER 40/52, AND OR3O DM XLPE INSERT 22/40 WERE EXPLANTED AND REPLACED WITH NEW SMITH & NEPHEW BACK-UP IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21932584 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR REVISION HAD BEEN PERFORMED ON (B)(6) 2020 TO TREAT A FAILED PREVIOUS HIP SURGERY DUE TO ELEVATED COBALT LEVELS FROM LAB RESULTS, THE PATIENT REQUIRED A HIP CORTICOSTEROID INJECTION AT TWO YEAR VISIT FOLLOW UP FOR HIP BURSITIS. THE OUTCOME OF THE PATIENT IS NOT KNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Inflammation

  MAUDE report 16246360 ↗
• InjuryJul 29, 2022Adverse 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 (B)(6) 2022, THE PATIENT EXPERIENCED A DISLOCATION THAT LED TO A REVISION SURGERY ON (B)(6) 2022, WHERE THE OXINIUM FEM HD 12/14 22 MM +0 WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15128778 ↗
• InjuryJun 16, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FROM DATA OBTAINED FROM THE NATIONAL JOINT REGISTRY (UK) FOR TWENTY THOUSAND SIXTY THREE (20063) PATIENTS WHO UNDERWENT PRIMARY IMPLANTATION OF THR - SMITH AND NEPHEW COMPONENTS COMPRISING A CEMENTLESS POLARSTEM AND A COMBINATION OF SEVERAL FEMORAL HEADS, LINERS AND CUPS BETWEEN 23-JUL-2007 AND 19-SEP-2021, A TOTAL OF TWO HUNDRED THIRTY ONE (231) HIPS WERE REVISED DUE TO SEVERAL REASONS, WHICH WERE ACCOUNTED FOR A TOTAL OF TWO HUNDRED SIXTY NINE (269) PREOPERATIVE DIAGNOSIS. FROM THESE, SIXTEEN (16) WERE INDICATED FOR A POSTOPERATIVE DIAGNOSIS OF UNEXPLAINED PAIN. SPECIFIC DETAILS IN REGARDS OF THE IDENTITY OF THE EXPLANTED COMPONENTS AND THE ONES IMPLANTED IN EXCHANGE ARE NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 14715111 ↗
• InjuryJun 13, 2022Device Appears to Trigger Rejection; Device Dislodged or Dislocated; Device Appears to Trigger Rejection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, FROM DATA OBTAINED FROM THE NATIONAL JOINT REGISTRY (UK) FOR TWENTY THOUSAND SIXTY THREE (20063) PATIENTS WHO UNDERWENT PRIMARY IMPLANTATION OF THR - SMITH AND NEPHEW COMPONENTS COMPRISING A CEMENTLESS POLARSTEM AND A COMBINATION OF SEVERAL FEMORAL HEADS, LINERS AND CUPS BETWEEN (B)(6) 2007 AND (B)(6) 2021, A TOTAL OF TWO HUNDRED THIRTY ONE (231) HIPS WERE REVISED DUE TO SEVERAL REASONS, WHICH WERE ACCOUNTED FOR A TOTAL OF TWO HUNDRED SIXTY NINE (269) PREOPERATIVE DIAGNOSIS. FROM THESE, EIGHT (8) WERE INDICATED FOR A POSTOPERATIVE DIAGNOSIS OF ADVERSE SOFT TISSUE REACTION. THE CONTRIBUTION OF THE POLARSTEM TO THIS OUTCOME COULD NOT BE DISCARDED AT THIS MOMENT. SPECIFIC DETAILS IN REGARDS OF THE IDENTITY OF THE EXPLANTED COMPONENTS AND THE ONES IMPLANTED IN EXCHANGE ARE NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Joint Dislocation

  MAUDE report 14682481 ↗
• InjurySep 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED ACUTE PAIN IN THE LEFT HIP AND THE LEFT PROSTHESIS WAS DISLOCATED. THE PATIENT UNDERWENT A REVISION SURGERY. THIS ISSUE IS STILL BEING RESOLVED.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 12538264 ↗
• InjuryJul 5, 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 A DISLOCATION WHILE STANDING AND PIVOTED. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021 TO EXCHANGE THE OXINIUM FEMORAL HEAD 12/14 22 MM +0 ((B)(4)) AND THE R3 CONST 54MM ((B)(4)). PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12117889 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY IN THE RIGHT HIP AND DISLOCATION. THERE IS A DISSOCIATION OF THE DUAL MOBILITY BEARING.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11417872 ↗
• InjuryMar 2, 2021Material Discolored; Scratched Material; Material Discolored; Scratched Material

  IT WAS REPORTED THAT, AN OXINIUM FEM HD 12/14 22 MM +0 AND AN R3 20 DEG XLPE ACET LNR 22MM X MM40 ARE DAMAGED. ACCORDING TO THE PICTURES ATTACHED, BOTH DEVICES SEEMED TO BE USED, PRESENT SCRATCHES, THE OXINIUM FEM HD 12/14 22 MM +0 IS DISCOLORED AND THE R3 20 DEG XLPE ACET LNR 22MM X MM40 IS DEFORMED. THESE PROBLEMS WERE DETECTED DURING PROCEDURE, AND PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402662 ↗
• MalfunctionNov 27, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT A REVISION THR OF A PERIPROSTHETIC FRACTURE WAS PERFORMED AROUND AN EXETER STEM AND UNITRAX BIPOLAR HEAD. THE PATIENT HAD A 44MM +0 EXETER STEM AND A 55MM BIPOLAR HEAD. THIS WAS REMOVED ALONG WITH THE CEMENT AND THE FEMORAL FRACTURE WAS REDUCED AND CABLED. THE INTENTION WAS TO USE AN R3 56MM CONSTRAINED LINER AND 22MM HEAD. THE ACETABULUM WAS REAMED 70 55MM AND A 56MM 3 HOLE R# CUP WAS IMPLANTED WITH ONE SCREW. A TRIAL 36MM LINER WAS INSERTED. THE FEMUR WAS PREPARED FOR AN ECHELON 265 X 16MM BOWED STEM. TRIALING WAS DONE USING A COUPLE OF 36MM HEAD LENGTHS. THE TRIAL LINER WAS REMOVED AND THE R3 56MM CONSTRAINED LINER WAS IMPLANTED. THE 22MM +0 OX HEAD WAS IMPLANTED AND THE HIP REDUCED. REDUCTION WAS DIFFICULT AS THE HIP WAS A LITTLE TIGHT. WHEN THE HEAD WAS REDUCED INTO THE LINER THERE WAS NO AUDIBLE CLICK OF THE HEAD LOCKING IN. DURING ROM TESTING IT WAS FOUND THAT WITH THE HIP AT 90DEG OF FLEXION AND 10DEG OF INTERNAL ROTATION THE HEAD WOULD DISLOCATE FROM THE LINER. REDUCTION WAS TRIED A NUMBER OF TIMES. THE SURGEON THEN IMPACTED THE STEM FURTHER TO MAKE THE JOINT LESS TIGHT. REDUCTION WAS DONE AGAIN BUT THE PROBLEM OF DISLOCATION IN THE SAME POSITION PERSI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384657 ↗
• InjuryNov 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY DUE TO DISLOCATION OF THE LEFT HIP.

  Patient problems: Injury

  MAUDE report 9268894 ↗
• InjuryDec 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO CHANGE THE LINER DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7140018 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, K024340, K030766, K211176, K240783. 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.