OXINIUM 71343600Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 03596010477279), received between Jun 15, 2017 and May 11, 2026 — classified as 75 injuries, 6 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 81 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS AND THAT THE LENGTH OF THE HIP REPLACEMENT WAS SHORTER THAN THE NON-OPERATIVE SIDE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) R3 0 DEG XLPE ACET LNR 36MM X 58MM WERE REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation; Unequal Limb Length

  MAUDE report 25136383 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED AN INFECTION IN THE JOINT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 52MM AND ONE (1) OXINIUM FEM HD 12/14 36 MM +0 WERE REMOVED AND NEW ONES IMPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24161212 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A TOTAL HIP REPLACEMENT SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THE EVENT WAS TREATED WITH AN ILIOPSOAS TENDON RELEASE ON (B)(6) 2025, DURING WHICH ONE OXINIUM FEM HD 12/14 36 MM +0 AND ONE R3 20 DEG XLPE ACET LNR 36MM X 52MM WERE EXCHANGED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23501340 ↗
• InjuryOct 17, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING A LEFT THR SURGERY, AFTER COMPLETING THE SURGERY WITH A OXONIUM FEM HD 12/14 36 MM +0 AND REDAPT SLVLS MONO STEM 190MM SZ 16 SO. AFTER CAREFUL MEASUREMENTS AND CHECKING STABILITY, THE SURGEON DECIDED THAT THE HEAD NEEDED TO BE SHORTENED. HE ATTEMPTED TO EXTRACT IT WITH INCREASINGLY STRONGER IMPACTS, WITHOUT SUCCESS. HE SPENT AN HOUR TRYING TO DISLODGE THE HEAD, AFTER WHICH, SINCE THE STEM WAS VERY STABLE, HE FINALLY DECIDED TO PERFORM A FEMORAL OSTEOTOMY SO HE COULD REMOVE THE STEM AND HEAD, WHICH COULD NOT BE DISLODGED. SUBSEQUENTLY, ANOTHER REDAPT STEM AND A CERAMIC HEAD WERE IMPLANTED. THE PROCEDURE WAS PERFORMED, AFTER 1 HOUR AND 30 MINUTES, USING AN EQUIVALENT S+N BEARING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324221 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY WAS PERFORMED ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO AN INFECTION THE FOLLOWING DEVICES WERE EXPLANTED: ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 52MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22713417 ↗
• InjuryNov 22, 2024Adverse 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) 2024, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION THR SURGERY ON (B)(6) 2024, IN WHICH ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 56MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 20762406 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT THA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INSTABILITY DUE TO A VERTICAL CUP. TO ADDRESS THIS ADVERSE EVENT, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE COMPONENTS WERE REVISED AND REPLACED WITH A NEW REVISION CUP, A LEFT ANTEVERTED NECK, AND A 36 MM+12 FEMORAL HEAD. THE EXISTING REDAPT MODULAR STEM, SIZE 15 HI OFFSET WITH A 240 MM LENGTH, WAS RETAINED BECAUSE IT WAS WELL FIXED AND APPROPRIATELY PLACED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20292153 ↗
• 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 36 MM +0 AND REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 STANDARD OFFSET) ALONG WITH COMPETITOR DEVICE FROM DEPUY (CABLE ORTHOPEDIC TITANIUM COCR 1.7MM 750MM CRIMP STERILE CERVICAL CERCLAGE). THE IDENTITY OF THE PRIMARY HIP SYSTEM IS UNKNOWN. LATER, ON THAT SAME MONTH PATIENT SUFFERED FROM AN UNSPECIFIED INFECTION THAT REQUIRED RE-REVISION SURGERY. ACETABULAR LINER FROM A COMPETITOR WAS EXPLANTED AS WELL AS THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0. 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 20241247 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF HER RIGHT THA SYSTEM (COMPETITOR PRODUCT) ON (B)(6) 2019 DUE TO ASEPTIC LOOSENING FOLLOWING RIGHT TOTAL HIP ARTHROPLASTY AND PERIPROSTHETIC FRACTURE FOLLOWING RIGHT TOTAL HIP ARTHROPLASTY. DURING THE REVISION SURGERY, THE FEMORAL COMPONENT AND THE BEARINGS WERE EXPLANTED AND REPLACED WITH A DEPUY LINER ACETABULAR, A SMITH AND NEPHEW REDAPT FEMORAL STEM, AND A SMITH AND NEPHEW OXINIUM FEMORAL HEAD. AS REPORTED, ON (B)(6) 2019, THE PATIENT SUFFERED FROM INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL RIGHT HIP PROSTHESIS AND WAS REVISED. DURING THIS SECOND REVISION SURGERY, THE FEMORAL HEAD, AND THE ACETABULAR LINER WERE EXPLANTED. 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 20202307 ↗
• MalfunctionAug 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TAPER JUNCTION OF A OXINIUM FEM HD 12/14 36 MM +0 BROKE ON TRIAL AND WOULD NOT ALIGN TO THE STEM. IT IS UNKNOW HOW THE PROCEDURE WAS COMPLETED AND WHETHER THERE WAS ANY DELAY. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20114315 ↗
• InjuryJun 13, 2023Adverse 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) 2013, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 TO EXCHANGE A OXINIUM FEM HD 12/14 36 MM +0 DUE TO INFECTION. AT THIS TIME, THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17121450 ↗
• MalfunctionMay 9, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP/ INSPECTION FOR A THR, IT WAS NOTICED THAT THE OUTER PACKAGING OF ONE (1) OXINIUM FEM HD 12/14 36 MM +0 HAD A HOLE, AS WELL AS THE INNER PACKAGING AND PRODUCT WAS DEEMED UNSTERILE AND COULD NOT BE USED. A REPLACEMENT WAS TAKEN FROM THE LOAN KIT WHICH WAS AT THE HOSPITAL. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897014 ↗
• InjuryMar 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT THA, ONE (1) PATIENT EXPERIENCED LOOSENING. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY COMBINED WITH INTERNAL FIXATION ON (B)(6) 2021, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP CONFIRMED A GOOD POSITION WITHOUT COMPLICATING FEATURES.

  Patient problems: Insufficient Information

  MAUDE report 16583124 ↗
• InjuryFeb 4, 2023Adverse 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) 2023, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS COMPLICATION. DURING THIS PROCEDURE, A WASH OUT IN THE WOUND AND HIP JOINT WAS PERFORMED WITH THE REMOVAL AND EXCHANGE OF ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 60MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16301758 ↗
• 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) 2014 DUE TO LOOSENING OF THE STEM, LOOSENING OF THE ACETABULAR CUP AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, THE PATIENT EXPERIENCED LOOSENING OF A COMPETITORS ACETUBLAR CUP AND UNEXPLAINED PAIN THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2014. DURING THIS PROCEDURE, THE COMPETITORS ACETABULAR CUP AND LINER WERE EXPLANTED, AS WELL AS THE SMITH & NEPHEW FEMORAL HEAD. 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); Pain

  MAUDE report 16284687 ↗
• InjuryJan 10, 2023Adverse 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) 2022, THE PATIENT SUFFERED A DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, IN WHERE A R3 3 HOLE HA CTD ACET SHELL 52MM, A R3 20 DEG XLPE ACET LNR 36MM X 52MM AND A OXINIUM FEM HD 12/14 36 MM +0 WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS WELL.

  Patient problems: Joint Dislocation

  MAUDE report 16134839 ↗
• InjuryDec 26, 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) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE MODULAR HEAD WAS EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW COMPONENT. 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 16047821 ↗
• InjuryDec 26, 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 SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON 24-JAN-18. 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 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 16047641 ↗
• InjuryNov 7, 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) 2012 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL HEAD 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

  MAUDE report 15741931 ↗
• InjuryNov 5, 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 TRAUMA - ACUTE SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL HEAD 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

  MAUDE report 15740890 ↗
• 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) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE FEMORAL STEAM 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

  MAUDE report 15740607 ↗
• 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) 2016 TO ADDRESS TRAUMA - ACUTE SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE FEMORAL HEAD, FEMORAL STEAM 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

  MAUDE report 15739588 ↗
• InjuryJun 16, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; 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, FIVE (5) WERE INDICATED DUE TO WEAR OF THE ACETABULAR COMPONENT. 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: Failure of Implant; Joint Dislocation

  MAUDE report 14715602 ↗
• MalfunctionJun 10, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, UPON OPENING OF BOX, THE STERILE PACKAGING OF AN OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0 WAS OBSERVED TO BE UNSEALED. THE DEVICE WAS REMOVED FROM THE OPERATING ROOM AND SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655064 ↗
• InjuryMay 4, 2022Material Erosion; Off-Label Use; Material Erosion; Off-Label Use

  IT WAS REPORTED THAT, AFTER A PARTIAL HIP ARTHROPLASTY HAD BEEN PERFORMED FIVE YEARS BEFORE, THE PATIENT UNDERWENT A REVISION SURGERY FOR CONVERSION TO TOTAL HIP ARTHROPLASTY ON 2016. IT IS UNKNOWN WHAT LED TO SUCH CONVERSION AND WHAT THE INVOLVED IMPLANTS WERE. ON THIS SURGERY, THE PATIENT RECEIVED AN UNAPPROVED COMBINATION OF DELTA MOTION (J&J) AND OXINIUM+POLARSTEM (S+N). ON 2022, AN X-RAY IMAGE WAS TAKEN AND SHOWED PULVERIZED TITANIUM DEBRIS FROM CATASTROPHIC WEAR OF OXINIUM HEAD. SIGNS OF METALLOSIS ARE EVIDENT. THIS WAS REFERRED TO A BIOPSY CENTER. IT IS UNKNOWN HOW THIS EVENT HAS BEEN TREATED THUS FAR, BUT A REVISION SURGERY WILL BE PERFORMED IN A COUPLE OF WEEKS. CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant; Infiltration into Tissue; Metal Related Pathology; Pain

  MAUDE report 14283196 ↗

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.