OXINIUM 71343603Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 03596010000675), received between May 24, 2017 and Mar 21, 2023 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT THA, ONE (1) PATIENT EXPERIENCED PAIN DUE TO TOTAL HIP REPLACEMENT. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP FOUND THE RIGHT TOTAL HIP SYSTEM IN A GOOD POSITION AND THE PATIENT TO BE WELL-HEALING.

  Patient problems: Implant Pain

  MAUDE report 16583076 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY, THE PATIENT HAD A FEMUR FRACTURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 IN ORDER TO EXPLANT AN OXINIUM FEM HD 12/14 36 MM -3, A POLARSTEM STEM STD TI/HA 3 NON-CEM AND A R3 0 DEG XLPE ACET LNR 36MM X 52MM, AND REPLACE THEM WITH OR3O AND A REDAPT 240MM STEM. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hip Fracture

  MAUDE report 16278254 ↗
• InjuryJan 12, 2023Adverse 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 SUFFERED FROM PAIN, WHICH MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE THE FEMORAL HEAD WAS EXPLANTED AND REPLACED. 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: Pain

  MAUDE report 16145733 ↗
• InjuryJan 11, 2023Adverse 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) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT PRESENTED AN UNSPECIFIED ADVERSE EVENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE THE FEMORAL HEAD WAS EXPLANTED AND REPLACED. 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: Insufficient Information

  MAUDE report 16143308 ↗
• InjuryDec 26, 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) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2015. 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 16047900 ↗
• InjuryJun 16, 2022Device Dislodged or Dislocated; 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 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, TWO (2) WERE INDICATED DUE TO DISSOCIATION OF THE ACETABULAR LINER. 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; Unspecified Infection

  MAUDE report 14715764 ↗
• InjuryApr 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A PRIMARY HIP REPLACEMENT IN (B)(6) 2019, PATIENT SUFFERED A TRAUMATIC FALL WITH DISLOCATION AND SOFT TISSUE DAMAGE. PATIENT HAD TWO MORE DISLOCATIONS AFTERWARDS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 IN WHICH THE SUPPORTING MUSCLES WERE NOTED TORN AND NEEDED TO BE REPAIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 14192345 ↗
• InjuryMar 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2022, REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REPLACE THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 DUE TO DISLOCATION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13690106 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT, AFTER A RIGHT 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) 2017 DUE TO PAIN. DURING THE REVISION, DEBRIDEMENT OF SKIN, MUSCLES AND BONES WAS PERFORMED, NOTING A SMALL AMOUNT OF FLUID WITH SOME PURULENCE. A PULSE IRRIGATION WAS PERFORMED WITH AN ANTIBIOTIC SOLUTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 12964864 ↗
• MalfunctionNov 3, 2021Break

  IT WAS REPORTED THAT AFTER VISUAL INSPECTION OF THE DEVICE MI TRIAL FEM HEAD 36 -3 IT WAS CONFIRMED THAT ONE OF THE TABS BROKE OFF THE DEVICE, RENDERING IT INOPERABLE.

  Patient problems: Failure of Implant

  MAUDE report 12746179 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6); SUBJECT: (B)(6); AE: 01 INFECTION. IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, DUE TO THE DEVELOPED OF PERIPROSTHETIC JOINT INFECTION A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 ((B)(6)) AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM ((B)(6)). THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 12538234 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6); AE: 01 INFECTION. IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, DUE TO THE DEVELOPED OF PERIPROSTHETIC JOINT INFECTION A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 (B)(4) AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM (B)(4). THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 12533991 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, DUE TO THE DEVELOPED OF PERIPROSTHETIC JOINT INFECTION OF STREPTOCOCCUS AGALACTIAE 2+, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM. ADDITIONALLY, THE PATIENT RECEIVED ANTIBIOTIC THERAPY TO CONTROL THE INFECTION. THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED, PATIENT DID NOT HAVE ANY PROBLEM WALKING AFTER THE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 12530465 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM DUE TO THE DEVELOPMENT OF PERIPROSTHETIC JOINT INFECTION OF METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA). ADDITIONALLY, THE PATIENT RECEIVED ANTIBIOTIC THERAPY TO CONTROL THE INFECTION. THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED, PATIENT DID NOT HAVE ANY PROBLEM WALKING AFTER THE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 12530350 ↗
• InjurySep 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY, ONE SYN POR FEM COMP SZ 13, ONE R3 3 HOLE ACET SHELL 56MM, ONE OXINIUM FEM HD 12/14 36 MM -3, AND ONE R3 20 DEG XLPE ACET LNR 36MM X 56MM WERE ASSOCIATED WITH A POST-OPERATIVE REACTION (PAIN, INFECTION AND UNHEALED INCISION). THIS HAPPENED AFTER USE IN PATIENT. THE ISSUE WAS RESOLVED WITH A REVISION SURGERY, IN WHICH THE SURGEON REMOVED ALL THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 12511044 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR ON (B)(6) 2009 A REVISION SURGERY WITH AN IRRIGATION AND DEBRIDEMENT HAS BEEN PERFORMED ON (B)(6) 2021 DUE TO A SUSPECTED INFECTION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12295532 ↗
• InjuryJul 5, 2021Adverse 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) 2021, THE PATIENT EXPERIENCED POST OPERATIVE WOUND INFECTION THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021. A R3 20 DEG XLPE ACET LNR 36MM X 56MM (CASE (B)(4)) AND OXINIUM FEM HD 12/14 36 MM-3 (CASE (B)(4)) WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12119143 ↗
• InjuryApr 26, 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 PRESENTED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE OXINIUM FEM HD 12/14 36MM -3, THE R3 20 DEG XLPE ACET LNR 36MM X 54MM AND THE SYN POR PLUS HA SO STEM SZ 12. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 11722569 ↗
• InjuryApr 23, 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 AN INFECTION. ELEVATED TEMPERATURE AND CRP NOTED. ALL IMPLANTS REMOVED AND CEMENT SPACER IMPLANTED. THE SURGEON DOES NOT ATTRIBUTE BLAME TO PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 11712900 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE SECOND SURGERY DUE TO THE FRACTURE ON AUGUST 2020 THE PATIENT GOT INFECTED THEREFORE IT WAS DONE A REVISION SURGERY ON 01/07/2021. ALL IMPLANTS WERE REMOVED. ( OXINIUM FEM HD 12/14 36 MM -3, REDAPT SLVLS MONO STEM 190MM SZ 19 SO, R3 3 HOLE ACET SHELL 58MM, R3 20 DEG XLPE ACET LNR 36MM X 58MM, TWO REF SPHER HEAD SCREW 20MM, THREE ACC 2.0MM COCR CABLE W/CLAMP.) THOSE IMPLANTS WERE REPLACED, EXCEPT FOR THE FLEXIBLE OSTEOTOMES USED TO REMOVE THE REDAPT SLVLS MONO STEM 190MM SZ 19 SO AND ALSO WAS IMPLANTED FOUR CC 2.0MM COCR CABLE W/CLAMP. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11263201 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THERE WAS A REVISION SURGERY BECAUSE THE PATIENT HAD TWO DISLOCATIONS. THE R3 0 DEG XLPE ACET LNR 36MM X MM56 AND OXINIUM FEM HD 12/14 36 MM -3 WERE EXPLANTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 11248369 ↗
• MalfunctionJul 17, 2020Crack; Crack

  IT WAS REPORTED THAT THE INNER FLANGES THAT ARTICULATE WITH THE TRIAL NECK/TRUNION ARE CRACKED OFF AND THE TRIAL HEAD WILL NOT ENGAGE. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10291946 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY OF PRIMARY THR (B)(6) 2020. IT WAS INFORMED THAT THE PATIENT HAD ANOTHER REVISION SURGERY IN (B)(6) 2020, BECAUSE IT PRESENTED A PERIPROSTHETIC FRACTURING FEMUR. THE SURGEON REMOVED THE FEMORAL PROSTHESIS AND THE FEMORAL HEAD. ALSO, IT WAS KNOWN THAT THE STEM WAS SUBSIDED. THE SURGEON FIXED THE PROBLEM WITH THREE CABLES. THE SURGEON DID NOT BLAME THE DEVICES IN THE DEVELOPMENT OF THE PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10224442 ↗
• InjuryApr 17, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAD SMITH+NEPHEW COMPONENTS SINCE (B)(6) 2019. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INSTABILITY AND CHRONIC DISLOCATIONS. THE CUP, LINER AND FEMORAL HEAD WERE REMOVED.

  Patient problems: Injury

  MAUDE report 9974977 ↗
• InjuryJul 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASONS. 36-3 OX HEAD WAS REMOVED. IT WAS REPLACED WITH COMPETITIVE PRODUCT. UNABLE TO READ LOT NUMBERS. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8787552 ↗

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.