OXINIUM 71342800Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 03596010474148), received between Dec 14, 2017 and Jun 5, 2026 — classified as 30 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, BEFORE A THA SURGERY AND AFTER OPENING THE OUTER BOX, IT WAS NOTICED THAT THE INNER SEAL OF ONE (1) OXINIUM FEM HD 12/14 28MM +0 HAD A HOLE IN IT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418065 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE OXINIUM FEM HD 12/14 28MM +0, THE OR3O DUAL MOBILITY LINER 42/54 AND THE OR3O DM XLPE INSERT 28/42 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24480016 ↗
• InjuryOct 10, 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 A CURRENTLY UNKNOWN DATE, PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED ON (B)(6) 2025 IN WHICH THERE WAS A WASHOUT OF THE WOUND. ADDITIONALLY, ONE (1) OXINIUM FEM HD 12/14 28MM +0, ONE (1) OR3O DUAL MOBILITY LINER 38/50 AND ONE (1) OR3O DUAL MOBILITY XLPE INSERT 28/38 WERE EXPLANTED AND REPLACED WITH EQUIVALENT S+N IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23268194 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED SWELLING AROUND THE IMPLANTED AREA. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH OXINIUM FEM HD 12/14 28MM +0 WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 22999703 ↗
• InjuryJul 18, 2025Adverse 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) 2015 IN WHICH ONE (1) R3 3 HOLE ACET SHELL 46MM, ONE (1) R3 0 DEG XLPE ACET LNR 28MM X 46MM, ONE (1) SL-PLUS STANDARD SIZE 3, ONE (1) OXINIUM FEM HD 12/14 28MM +0, AND ONE (1) REF SPHER HEAD SCREW 30MM WERE IMPLANTED THE PATIENT EXPERIENCED A FEELING OF WRONGNESS AND DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) OXINIUM FEM HD 12/14 28MM +0 AND ONE (1) R3 0 DEG XLPE ACET LNR 28MM X 46MM WERE EXPLANTED AND REPLACED WITH IMPLANTS OF THE SAME TYPE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Joint Dislocation

  MAUDE report 22541765 ↗
• InjuryJul 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A BHR-THA REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED THREE CONSECUTIVE DISLOCATIONS (ON (B)(6) 2023). THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, WHERE THE ACETABULAR CUP HAP SIZE 48/54, THE 48/28MM BH DUAL MOBILITY INSERT AND THE OXINIUM FEMORAL HEAD 12/14 TAPER 28 MM +0 WERE EXCHANGED FOR ZIMMER BIOMET (COMPETITOR¿S) DEVICES. FURTHERMORE, DURING SURGERY, IT WAS NOTICED THAT THE PATIENT HAD PERIPROSTHETIC OSTEOLYSIS UNDERNEATH THE INFERIOR MARGIN OF THE ACETABULAR SHELL WHERE A SIGNIFICANT PSEUDOTUMOR WAS PRESENT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM, EXTUBATED AND IN STABLE CONDITION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Cyst(s); Joint Dislocation; Muscle/Tendon Damage; Osteolysis

  MAUDE report 17347756 ↗
• InjuryMay 11, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER UNDERGOING LEFT THA REVISION ON (B)(6) 2022, THE PATIENT DEVELOPED A SEROMA ON THE LEFT HIP FOR WHICH HE ENTERED THE SURGICAL ROOM ON (B)(6) 2022, FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE WITH ANTIBIOTIC BEAD PLACEMENT. DAYS LATER, ON (B)(6) 2022 THE PATIENT REQUIRED A CT GUIDED ASPIRATION FOR LEFT HIP ABSCESS REMOVAL. AFTER THIS PROCEDURE, THE PATIENT WAS FOUND TO PRESENT A PERIPROSTHETIC JOINT INFECTION WITH PERSISTENT WOUND DRAINAGE. THIS EVENT WAS ADDRESSED BY PERFORMING A SECOND LEFT HIP REVISION ON (B)(6) 2022, IN WHICH THE FEMORAL HEAD AND LINER WERE EXPLANTED AND EXCHANGED WITH NEW IDENTICAL DEVICES. THE PATIENT WAS THEN TRANSFERRED TO THE HOSPITAL BED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Medical device site infection; Seroma

  MAUDE report 16911648 ↗
• 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 MODULAR HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A COMPETITORS FEMORAL HEAD AND A SMITH AND NEPHEW POLYETHYLENE LINER. 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 15729179 ↗
• 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) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. 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 15728489 ↗
• 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) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE ACETABULAR LINER AND THE FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A NEW 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 15725602 ↗
• InjurySep 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER THE THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED LEFT PROSTHETIC HIP DISLOCATION, WHERE THE FEMORAL HEAD DISSOCIATED FORM THE OR30 INSERT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. THE SITUATION WAS RESOLVED.

  Patient problems: Arthralgia; Failure of Implant; Joint Dislocation

  MAUDE report 15426416 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT LED TO A REVISION SURGERY ON (B)(6) 2018. THE STEM, FEMORAL HEAD AND LINER WERE EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15080888 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED DISLOCATION AND/OR SUBLUXATION OF THE JOINT PROSTHESIS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE OXONIUM FEM HD 12/14 28 MM +0 WAS EXPLANTED AND EXCHANGED WITH COMPETITORS' DEVICES. THE PATIENT'S OUTCOME IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 15079584 ↗
• InjuryJun 16, 2022Fracture; Device Dislodged or Dislocated; Fracture; 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, SIX (6) WERE INDICATED DUE TO POSTOPERATIVE FRACTURE OF THE FEMORAL STEM 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: Failure of Implant; Joint Dislocation

  MAUDE report 14719521 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP BHR-THA REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2020 FOLLOWING A METALLOSIS AND FAILED TOTAL HIP ARTHROPLASTY DIAGNOSIS (CASE (B)(4)), THE PATIENT EXPERIENCED A CHRONIC AND RECALCITRANT PROSTHETIC JOINT INFECTION. DESPITE MULTIPLE OPERATIONS TO ADDRESS THE INFECTION IN WHICH AN ANTIBIOTIC SPACER WAS PLACED, A RESECTION ARTHROPLASTY WAS CONDUCTED ON (B)(6) 2021 TO FURTHER TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR LINER AND THE FEMORAL STEM WERE EXPLANTED AND A COPIOUS SALINE IRRIGATION WITH EXCISIONAL DEBRIDEMENT ON BONY SURFACES WAS PERFORMED. INTRAOPERATIVELY, SIGNIFICANT DEBRIS AND APPARENT HEMATOMA OR INFECTION WAS EVIDENT. SERIAL SEQUENTIAL WASHES WERE PERFORMED ON THE DEBRIDED SURFACES, WITH A SUBSEQUENT PLACEMENT OF STIMULANT BEADS INCLUDING VANCOMYCIN AND LIQUID TOBRAMYCIN. THE ARTHROTOMY, FASCIA AND SKIN WERE CLOSED, UNTIL FURTHER EVALUATION OF THE CLINICAL COURSE OF THE PATIENT WAS OBTAINED TO PERFORM A DEFINITIVE RECONSTRUCTION. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN (CASE (B)(4)).

  Patient problems: Hematoma; Sepsis; Unequal Limb Length; Unspecified Infection

  MAUDE report 14570612 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HEMI-ARTHROPLASTY WAS PERFORMED ON (B)(6)2022, THE PATIENT EXPERIENCED HIP INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE TO TOTAL; HOWEVER, DURING THE SURGERY IT WAS FOUND THAT THE SYN CEM FEM COMP SZ 14 WAS LOOSE AND PULLED OUT WITH EASE. ALSO, IT WAS FOUND THAT THERE WAS A POSSIBLE PATIENT INFECTION, AND THAT NO BONE CEMENT WAS BONDED TO STEM. THEREFORE, THE TANDEM BIPOLAR COCR 53OD 28ID, THE INVIS DIST CENT SZ 11MM AND THE OXINIUM FEM HD 12/14 28MM +0 WERE EXPLANTED ALONG WITH THE STEM. THE PATIENT IS CURRENTLY ON THE FIRST STAGE OF A TWO-STAGES REVISION SURGERY, FOR WHICH A CEMENT SPACER IS BEING USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 14545535 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A LEFT BHR SURGERY WAS PERFORMED ON (B)(6) 2007 DUE TO PROGRESSING DISABLING OF BOTH HIPS, PAIN, AND AVASCULAR NECROSIS, THE PATIENT SUFFERED LEFT HIP IMPINGEMENT, FOR WHICH LEFT REVISION SURGERY WAS CONDUCTED ON (B)(6) 2007. AFTER THAT EVENT, THE PATIENT EXPERIENCED HETEROTOPIC OSSIFICATION AND ELEVATED METAL IONS, FOR WHICH A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT EXPERIENCED PARTIAL SCIATIC NERVE PALSY, LEG LENGTH DISCREPANCY AND LEFT HIP GREATER TROCHANTERIC FRACTURE. THIS ADVERSE EVENT WAS TREATED WITH A THIRD REVISION SURGERY ON (B)(6) 2021. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Hip Fracture; Nerve Damage; Unequal Limb Length

  MAUDE report 14466746 ↗
• MalfunctionSep 9, 2021Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem; Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem

  IT WAS REPORTED THAT FOUR (4) OXINIUM FEMORAL HEADS 12/14 TAPER 28MM HAD MANUFACTURING LABELS THAT WERE CUT OFF AND DID NOT FULLY DISPLAY THE PART NUMBER, LOT NUMBER, QUANTITY AND EXPIRATION DATE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447645 ↗
• MalfunctionSep 2, 2021Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem; Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN OXINIUM FEMORAL HEAD 12/14 TAPER 28MM HAD MANUFACTURING LABEL THAT WAS CUT OFF AND DID NOT FULLY DISPLAY THE PART NUMBER, LOT NUMBER, QUANTITY AND EXPIRATION DATE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12417091 ↗
• MalfunctionSep 2, 2021Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem; Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem

  IT WAS REPORTED THAT FOUR (4) OXINIUM FEMORAL HEADS 12/14 TAPER 28MM HAD MANUFACTURING LABELS THAT WERE CUT OFF AND DID NOT FULLY DISPLAY THE PART NUMBER, LOT NUMBER, QUANTITY AND EXPIRATION DATE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416970 ↗
• MalfunctionSep 2, 2021Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem; Tear, Rip or Hole in Device Packaging; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A OXINIUM FEMORAL HEAD 12/14 TAPER 28MM HAD MANUFACTURING LABEL THAT WAS CUT OFF AND DID NOT FULLY DISPLAY THE PART NUMBER, LOT NUMBER, QUANTITY AND EXPIRATION DATE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416881 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED DISLOCATION/SUBLUXATION. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 WHERE R3 0 HOLE HA CTD ACET SHELL 48MM ((B)(4)), R3 20 DEG XLPE ACET LNR 28MM X 48MM ((B)(4)), OXINIUM FEM HD 12/14 28MM +0 ((B)(4)) AND POLARSTEM STEM STD TI/HA 01 NON-CEM ((B)(4)) WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY FOR (B)(6) AND THE ISLE OF MAN SUPPLIER FEEDBACK; THEREFORE, FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 12240764 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A 1ST STAGE REVISION HIP ARTHROPLASTY FOR INFECTION. IMPLANTS WERE EXPLANTED AND SENT TO LOCAL PATHOLOGY FOR SONIFICATION/INFECTION IDENTIFICATION. SINUS TRACK FROM SKIN WOUND INTO DEEP TISSUE/JOINT WAS NOTED DURING SURGERY, ALONG WITH 'FOUL ODOUR' AND HEAMOSEROUS OOZE/PUS. TYPE OF BACTERIA NOT KNOWN AT TIME OF SURGERY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11696284 ↗
• InjuryFeb 15, 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 DISLOCATION BETWEEN THE LINER AND THE FEMORAL HEAD. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11326454 ↗
• InjurySep 23, 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 UNKNOWN REASONS. HEAD AND LINER EXPLANTED. PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10577867 ↗

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.