OXINIUM 71342804Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03596010474162), received between Apr 17, 2017 and Sep 17, 2024 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT REVISION SURGERY IN (B)(6) 2022 DUE TO A PERIPROSTHETIC FRACTURE. DURING THE REVISION SURGERY SMITH & NEPHEW DEVICES WERE IMPLANTED (OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4 AND REDAPT 190MM SLEEVELESS REVISION STEM SIZE 17 STANDARD OFFSET) ALONG WITH COMPETITOR DEVICES FROM STRYKER (LINER AND INSERT). THE IDENTITY OF THE PRIMARY HIP SYSTEM IS UNKNOWN. LATER, ON (B)(6) 2022 PATIENT SUFFERED FROM AN UNSPECIFIED INFECTION THAT REQUIRED RE-REVISION SURGERY. ACETABULAR LINER AND INSERT FROM STRYKER WERE EXPLANTED AS WELL AS THE OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20241212 ↗
• InjuryFeb 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2022, THE PATIENT'S HIP DISLOCATED SEVERAL TIMES IN THE WEEKS TO FOLLOW AND DURING CLOSED REDUCTION PERFORMED ON (B)(6) 2022, ONE (1) OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +4 DISSOCIATED FROM ONE (1) OR3O DUAL MOBILITY XLPE INSERT 28/44. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 AND CONSTRUCT WAS CONVERTED TO A CONSTRAINED R3 LINER.

  Patient problems: Joint Dislocation

  MAUDE report 16283442 ↗
• InjuryNov 4, 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) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION AND INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL HEAD, FEMORAL STEM AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SIMILAR DEVICES. 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; Unspecified Infection

  MAUDE report 15730556 ↗
• InjuryJun 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER REVISION OF A TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED AROUND EIGHT (8) WEEKS AGO, THE PATIENT WAS DOING WELL. AT HER SIX-WEEK POSTOPERATIVE VISIT, PATIENT EXPRESSED ABSOLUTELY NO PAIN AND EVERYTHING WAS DOING VERY, VERY WELL. ABOUT ONE WEEK AGO, SOMETHING HAPPENED AND PATIENT DISLOCATED HER HIP. PATIENT SAID THAT SHE FLEXED HER HIP PAST 90 DEGREES IN THE SHOWER, ROTATED INTERNALLY AND THEN ADDUCTED HER FEMUR. THIS CAUSED THE FIRST DISLOCATION. OVER ONE WEEK SHE HAD TWO SUBSEQUENT DISLOCATIONS. A REVISION ARTHROPLASTY WAS PRESCRIBED TO CORRECT THE POSITION OF ACETABULAR COMPONENT. AFTER THE FASCIA WAS OPENED, SURGICAL TEAM FOUND THE POLYETHYLENE LARGE BALL SITTING IN THE SOFT TISSUES INDEPENDENT OF THE OXINIUM FEMORAL HEAD, WHICH WAS STILL AFFIXED SUPERIORLY TO THE TRUNNION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 14820590 ↗
• 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, NINE (9) WERE INDICATED DUE TO MALALIGNMENT OF THE ACETABULAR CUP PROSTHESIS. THE 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: Deformity/ Disfigurement; Joint Dislocation

  MAUDE report 14715294 ↗
• 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 (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, FOUR (4) WERE INDICATED DUE TO A PERIPROSTHETIC FRACTURE ASSOCIATED TO THE ACETABULAR CUP AREA. THE 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: Bone Fracture(s); Joint Dislocation

  MAUDE report 14711275 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TWO REVISION SURGERY, THE PATIENT EXPERIENCED LEFT TOTAL HIP RECURRENT INSTABILITY. THE ISSUE WAS INITIALLY ADDRESSED WITH A LEFT HIP THA REDUCTION UNDER SEDATION AND PARALYSIS. HOWEVER, THE PROBLEM WAS NOT SOLVED, AND A THIRD REVISION SURGERY WAS PERFORMED ON 08- JUN-2021 WHERE THE FEMORAL HEAD WAS REMOVED AND ANOTHER FROM S-N WAS IMPLANTED INSTEAD. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12953915 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2013 WITH A REF THREE HOLE SHELL 48 MM (B)(4), REF XLPE 22 0 DEG 46-48 SZ (B)(4) AND A OXONIUM FEM HD 12/14 28 MM +4 (B)(4), A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO OSTEOLYSIS. THE PRODUCTS WERE REPLACED TO COMPETITOR'S PRODUCTS. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 12898460 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12537228 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THA, AN UNKNOWN FEMORAL HEAD MEMPHIS OX AND AN UNKNOWN R3 LINER CERAMIC POLY WERE DISLOCATED WHICH LED TO REVISION SURGERY. SURGERY HAD BEEN COMPLETED WITH A BACK-UP DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12164423 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY (IMPLANTATION OF A CEMENTLESS TOTAL HIP PROSTHESIS) WAS PERFORMED ON (B)(6) 2018 TO A VERY HEAVY PATIENT AND THE OUTCOME WAS GOOD. ON (B)(6) 2020, THE PATIENT REPORTED THAT A "PAINLESS CRACKING" OCCURRED IN THE LEFT HIP JOINT. THE NATIVE RADIOLOGY SHOWED CORRECT POSITIONING OF THE METALLIC PROSTHESIS COMPONENTS WITHOUT SIGNS OF LOOSENING OR INFECTION; HOWEVER, THE HEAD OF THE PROSTHESIS WAS CLEARLY DECENTERED IN THE SOCKET. THE SCINTIGRAPHY PERFORMED SHOWED NO EVIDENCE OF LOOSENING OR INFECTION OF THE PROSTHESIS. A REVISION SURGERY OF THE LEFT HIP JOINT WAS PERFORMED ON (B)(6) 2020. INTRAOPERATIVELY, THERE SHOWED ADVANCED DESTRUCTION OF THE INLAY WITH CORRESPONDING DAMAGE TO THE OXINIUM BALL HEAD.

  Patient problems: Failure of Implant

  MAUDE report 11123620 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED A DISLOCATION AFTER A FALL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXCHANGE THE OXINIUM FEMORAL HEAD. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10815696 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATION. HEAD AND LINER WERE EXPLANTED AND CHANGED FOR PATS OF THE SAME SIZE. THE OTHER IMPLANTS REMAINED IN SITU. NO INFORMATION ABOUT THE PATIENT STATUS WAS INITIALLY PROVIDED.

  Patient problems: Injury

  MAUDE report 10652445 ↗
• InjurySep 25, 2020Device 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, AFTER A THA HAD BEEN PERFORMED WITH AN OR3O CONSTRUCT, THE PATIENT SUFFERED A DISLOCATION AS THE HEAD PULLED OUT OF THE INSERT. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE 56 DM INSERT AND THE 28+4 OXINIUM FEMORAL HEAD. THE 56 OXINIUM LINER WAS ALSO EXPLANTED AS THE PATIENT RECEIVED AN R3 SYSTEM INSTEAD OF THE ORIGINAL OR3O SYSTEM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10590309 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DRAINING POSTOPERATIVE HEMATOMA. THE LINER AND THE HEAD WERE REMOVED AND REPLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Hematoma; Injury

  MAUDE report 10405973 ↗
• InjuryApr 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM A RIGHT HIP DISLOCATION. THE PATIENT HAD A HISTORY OF MULTIPLE DISLOCATIONS OCCURRING ON THE SAME HIP SIDE.

  Patient problems: Injury

  MAUDE report 9928561 ↗
• MalfunctionJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER DISASSOCIATED FROM HEAD WHEN THE LIP OF THE CUP INTERPOSED ITSELF BETWEEN THE LINER AND HEAD. BOTH DEVICES WERE REASSEMBLED WITH NO SUCCESS. SURGEON DECIDED TO USE ENTIRE NEW IMPLANTS SINCE NO BACKUP WAS AVAILABLE. DELAY NO GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568414 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE CONSEQUENCES OF HIS RIGHT HIP REPLACEMENT, STILL EXHIBITING A JUMP PHENOMENON THAT ALMOST PERMANENTLY INVALIDATES AND HINDERS OVERALL RECOVERY.

  Patient problems: Injury

  MAUDE report 9315163 ↗
• InjurySep 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT HIP REVISION SURGERY OF SMF STUDY WAS PERFORMED DUE TO PAIN AND METAL IONS IN BLOOD.

  Patient problems: Injury

  MAUDE report 9083519 ↗
• InjuryAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION TO REMOVE HEAD AND COMPETITOR'S LINER.

  Patient problems: Injury

  MAUDE report 8929184 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT HIP DISLOCATION OCCURRED. JOINT REDUCTION WAS PERFORMED TO CORRECT THE PROBLEM.

  Patient problems: Joint Dislocation

  MAUDE report 8519419 ↗
• InjuryApr 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO OXINIUM HEAD SEPARATED FROM THE TRUNION ON THE SIZE 1 ANTHOLOGY STEM AND DID NOT DISLODGE FROM THE ZIMMER CONSTRAINED LINER.

  Patient problems: Injury

  MAUDE report 8483296 ↗
• InjuryFeb 18, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED A THA REVISION SURGERY IN AN ARTICLE DUE TO DISLOCATION. DISASSOCIATION OF THE ACETABULAR LINER FLATTENING THE FEMORAL HEAD. STEM AND ACETABULAR CUP LOOSE AND EFFORTLESS REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 8348860 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT OXINIUM FEMORAL HEAD WAS REVISED DUE TO PATIENT WAS NON COMPLIANT WITH POST OPERATIVE PRECAUTIONS, THEN HAD RECURRENT DISLOCATIONS OF HIP.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7974354 ↗
• InjuryOct 1, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CPCS R3 REVISED FOR DISLOCATION. HIP STABLE ON TABLE. IMPINGE ANTERIOR ACETABULAR OSTEOPHYTE. HEAD STEM LINER & SCREWS REMOVED. POLAR CUP CEMENTED INTO SHELL. SMALLER STEM CEMENTED. POLAR ARTICULATION STABLE. NIL IMPLANTS FOR RETRIEVAL.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7924584 ↗

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.