OXINIUM 71343203Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010474216), received between Oct 27, 2017 and Dec 27, 2023 — classified as 28 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K021673, 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, WHEN A THR REVISION WAS PERFORMED ON (B)(6) 2023 TO REMOVE A COMPETITOR'S IMPLANT (CORAIL STEM), A REDAPT STEM SIZE 6 WAS PLACED IN EXCHANGE AND THE COMPETITOR¿S CUP WAS RETAINED. A 32MM OXINIUM FEMORAL HEAD 12/14 WAS IMPLANTED AS WELL. SOME MONTHS AGO, THE PATIENT EXPERIENCED DISLOCATION, WHICH WAS ADDRESSED BY PERFORMING A SECOND REVISION SURGERY ON (B)(6) 2023. DURING THIS PROCEDURE, THE COMPETITOR¿S ACETABULAR CUP WAS REMOVED ALONG WITH THE 32MM OXINIUM FEMORAL HEAD 12/14. THE REDAPT STEM REMAINED IN SITU. A NEW OR3O DUAL MOBILITY CUP WAS IMPLANTED. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18403229 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR THAT WAS PERFORMED ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DUE TO PAIN AND FRACTURE FROM A FALL. A POLARSTEM STEM STD TI/HA 2 NON-CEM AND AN OXONIUM FEM HD 12/14 32MM -3 WERE EXTRACTED AND REPLACED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16829716 ↗
• 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 ON (B)(6) 2019 DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, THE PATIENT EXPERIENCED DISLOCATION/SUBLUXATION THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE FEMORAL HEAD AND ACETABULAR LINER WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), 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); Joint Dislocation

  MAUDE report 16284148 ↗
• InjuryFeb 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL HEAD AND 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 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: Subluxation

  MAUDE report 16283977 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2021 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE MODULAR HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW BEARING COMBINATION. THIS INFORMATION WAS PROVIDED BY (B)(6), 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 16043305 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON 1-JUN-2020. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENTS. 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 16042888 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THA PERFORMED ON (B)(6) 2022, ON WHICH TRIALS WERE USED TO CONFIRM THE CORRECT SIZE AND INTRAOPERATIVE X-RAYS WERE USED TO CONFIRM THE CORRECT PLACEMENT OF THE OXINIUM FEM HD 12/14 32MM -3 DEVICE, THE SURGEON IDENTIFIED A LEG LENGTH DISCREPANCY RESULTING FROM THE LARGER IMPLANT, THEREFORE, A REVISION SURGERY WAS PERFORMED AND DOWNSIZED DEVICE WAS IMPLANTED. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unequal Limb Length

  MAUDE report 15789127 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE ACETABULAR LINER AND THE FEMORAL HEAD WERE EXPLANTED 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15728887 ↗
• InjurySep 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A THR PROCEDURE HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED INSTABILITY AND DISLOCATION FROM DEVICES. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 15433959 ↗
• InjuryJun 27, 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) 2019 THE PATIENT PRESENTED RECURRENT DISLOCATION. THEREFORE, A REVISION SURGERY WAS PERFORMED ON 23-FEB-2022 IN ORDER TO TREAT THIS ADVERSE EVENT, IN WHICH THE OXINIUM FEM HD 12/14 32MM -3 WAS REMOVED AND REPLACED WITH A NEW OXINIUM FEMORAL HEAD. THE PRIMARY SYNERGY STEM WAS LEFT IN-SITU. THE SURGEON DOES NOT BLAME THE IMPLANTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 14836693 ↗
• InjuryMay 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2018, THE PATIENT EXPERIENCED DISLOCATION ON THE RIGHT SIDE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 TO REVISE THE OXINIUM FEM HD 12/14 32MM -3. OUTCOME RECOVERED AND RESOLVED.

  Patient problems: Joint Dislocation

  MAUDE report 14507145 ↗
• InjuryDec 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 WITH DIRECT ANTERIOR APPROACH ON (B)(6) 2021, THE SURGEON IDENTIFIED ON POST OP X-RAY FRACTURE OF FEMUR DISTAL TO TIP OF FEMORAL IMPLANT. SO, ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED, SURGEON CHOSE TO LEAVE PRIMARY STEM INSIDE THE PATIENT AND UTILIZED CABLES TO STABILIZE THE FRACTURE, BUT THE OXONIUM FEMORAL HEAD 12/14 TAPER 32MM -3 WAS REPLACED THROUGH DIRECT ANTERIOR APPROACH. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 13087555 ↗
• InjuryDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED IMPLANT DISLOCATION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, IN WHICH BOTH R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM -3 WERE REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 13011066 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED FRACTURE OF GREATER TUBEROSITY. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH AN OXINIUM FEM HD 12/14 32MM -3 AND A POLARSTEM STEM LAT.TI/HA 2 NON-CEM WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 12583561 ↗
• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO PAIN AND DISLOCATION OF THE OXONIUM FEMORAL HEAD 12/14 TAPER 32 MM -3 AND THE POLARSTEM STANDARD NON-CEMENTED WITH TI/HA 5, THE SURGEON SAID THE DEVICES WERE NOT DEFECTIVE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12446825 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP SURGERY THE PATIENT FELT PAIN. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY TO REMOVE AN OXINIUM FEM HD 12/14 32MM -3. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 11781906 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A PRIMARY RIGHT THR, THE PATIENT PRESENTED PAIN IN THE JOINT, PSEUDOTUMOR FORMATION AND MECHANICAL LOOSENING OF THE JOINT PROSTHESIS. A REVISION SURGERY WAS PERFORMED TO EXPLANT A SMF STEM WITH STIKTITE SZ 2, OXINIUM FEMORAL HEAD 12/14 32MM -3 AND A R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Laceration(s); Metal Related Pathology; Osteolysis; Pain; Unequal Limb Length

  MAUDE report 11736185 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR PERFORMED ON (B)(6) 2019 DUE TO DEGENERATIVE ARTHRITIS. PATIENT COMPLAINTS OF PAIN. X-RAYS AND BONE SCAN CONFIRMED ECCENTRIC ACETABULAR WEAR WITH SUPERIOR MIGRATION OF THE FEMORAL HEAD COMPATIBLE WITH EARLY POLY-DEGRADATION. PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2021 IN WHICH THE FEMORAL HEAD AND LINER WERE EXPLANTED, AND NEW SMITH-NEPHEW DEVICES WERE IMPLANTED IN ITS PLACE. THE PLAINTIFF'S OUTCOME IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Pain

  MAUDE report 11689116 ↗
• InjuryNov 27, 2020Adverse 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 AN INFECTION. THE OXINIUM FEM HEAD AND R3 20 DEG XLP ACET LNR 32 MM X 60 MM WERE REVISED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10913453 ↗
• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF THR WAS PERFORMED. THE PATIENT WAS TAKEN IN FOR HIP PAIN AND POSSIBLE INFECTION. THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT, AND THE R3 0 DEGREES XLPE ACETABULAR LINER 32MM X 50MM ((B)(4)) AND OXINIUM FEMORAL HEAD 12/14 32MM -3 ((B)(4)) WERE EXCHANGE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10616824 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION ONE MONTH AFTER THE PRIMARY PROCEDURE. OXONIUM FEMORAL HEAD 12/14 TAPER 32MM -3 WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9831372 ↗
• InjuryOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, ALL PRIMARY COMPONENTS WERE EXPLANTED AND REPLACED WITH A THR SYSTEM FROM A COMPETITOR MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 9253225 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RECENT ONSET OF PAIN, BLOOD TEST AND ASPIRATION WERE NEGATIVE FOR INFECTION. LINER AND HEAD WERE REMOVED, WASHOUT PERFORMED, SPECIMENS TAKEN NO OBVIOUS INFECTION.

  Patient problems: Pain

  MAUDE report 8661083 ↗
• InjuryFeb 11, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD AN ECHELON STEM WITH OXINIUM HEAD IN A PROCEDURE DONE AT NCPH ON (B)(6) 2018. DR. USED ANOTHER COMPANY'S ACETABULUM COMPONENTS. THIS PATIENT HAD A DISLOCATION REPORTING TO TECH & DR. MADE THE DECISION TO EXCHANGE THE ACETABULUM COMPONENTS, AGAIN USING ANOTHER COMPANY, HOWEVER HE REQUIRED A SMALLER SIZED OXINIUM HEAD DUE TO USING A CONSTRAINED LINER. NOTHING WRONG WITH THE ORIGINAL HEAD, EXCHANGED DUE TO SIZE REQUIREMENTS ONLY.

  Patient problems: Joint Dislocation

  MAUDE report 8326209 ↗
• InjuryOct 19, 2018Break; Break

  IT WAS REPORTED THAT THIS IMPLANT WAS FOUND BROKEN ON THE PATIENT.

  Patient problems: Injury

  MAUDE report 7986790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, 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.