OXINIUM 71343200Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 03596010474209), received between May 5, 2017 and Jun 20, 2026 — classified as 55 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A HIP REPLACEMENT SURGERY, ONE (1) POLARSTEM DETACHABLE RASP 1, ONE (1) POLARSTEM DETACHABLE RASP 2, ONE (1) POLARSTEM TRIAL NECK STANDARD AND ONE (1) OXINIUM FEM HD (B)(6) 32MM +0 WERE HAVING FITTING ISSUES. THE PROCEDURE WAS RESUMED, AFTER 30 MINUTES OR LESS, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25570318 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE OXINIUM FEM HD 12/14 32MM +0 WAS REMOVED. THE COMPETITOR'S CUP AND LINER WERE ALSO REMOVED. THE S+N STEM REMAINED. PATIENT' CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23347890 ↗
• InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A OXINIUM FEM HD 12/14 32MM +0, R3 20 DEG XLPE ACET LNR 32MM X AND THE R3 MULTI HOLE ACETABULAR SHELL WERE EXCHANGED. THE SL-PLUS MIA STEM WITH TI/HA SI IS REMAINED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19402116 ↗
• InjuryFeb 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2018, PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE OXINIUM FEM HD 12/14 32MM +0 WAS EXCHANGED TO OXINIUM HEAD. THE R3 0 DEG XLPE ACET LNR 32MM X 52MM, R3 3 HOLE ACET SHELL 52MM AND SL-PLUS INTEGR MIA STEM LAT. W. TI/HA 2 WERE REMAINED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 18730853 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A REVISION SURGERY OF THE RIGHT HIP DUE TO THE COLLAPSE OF THE STEM AND SHORTENING OF THE LEG. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A LARGER ONE AND THE STEM WAS NOTICED TO BE NICELY POSITIONED. THE PATIENT HAD THE PRIMARY POLARSTEM - REFLECTION RIGHT HIP SURGERY ON (B)(6) 2017.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; Unequal Limb Length

  MAUDE report 17456396 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE THE MODULAR HEAD AND THE ACETABULAR 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: Insufficient Information

  MAUDE report 16155146 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2015 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE THE MODULAR HEAD WAS 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: Insufficient Information

  MAUDE report 16155037 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2014 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2015. DURING THIS PROCEDURE, THE MODULAR HEAD AND ACETABULAR 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: Insufficient Information

  MAUDE report 16155010 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2020 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW 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 16048123 ↗
• 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 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 WAS EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW DEVICE. 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 16048010 ↗
• 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 SURGERY PERFORMED ON (B)(6) 2017 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE MODULAR HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW 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 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 16045562 ↗
• MalfunctionDec 15, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE OXINIUM FEMORAL HEAD 12/14 32MM +0T WAS FOUND TO BE SCRATCHED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE OF THE SAME SIZE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15985421 ↗
• InjuryDec 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT SUFFERED FROM RECURRENT DISLOCATIONS OF THE LEFT HIP ON (B)(6) 2018 AND (B)(6) 2019. BOTH EVENTS WERE TREATED VIA CLOSED REDUCTION FOR WHICH THE PATIENT WAS SEDATED. THE FIRST DISLOCATION OCCURRED 3 WEEKS AFTER THE PATIENT UNDERWENT A LEFT HIP REVISION SURGERY ON (B)(6) 2018. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15902008 ↗
• InjuryNov 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2022 WITH AN OXINIUM FEM HD 12/14 32MM +0, WHILE CHECKING LEG LENGTH AND OFFSET WITH INTRAOPERATIVE X-RAY AND STABILITY CHECK BY SURGEON, THE PATIENT DISLOCATED THEIR HIP, RETURNED TO THEATRE AND SURGEON PERFORMED A CLOSED REDUCTION. THE PATIENT THEN DISLOCATED AGAIN. PATIENT WAS STILL IN BED WHEN DISLOCATED, HAD NOT MOBILIZED AFTER SURGERY PRIOR TO DISLOCATING. THE SURGEON MADE THE DECISION TO BRING THE PATIENT BACK TO THEATRE THE FOLLOWING MORNING (B)(6) 2022) TO PERFORM OPEN REDUCTION AND FEMORAL HEAD EXCHANGE. THE SURGEON PERFORMED AN X-RAY PRIOR TO REVISING THE HIP, STATING AGAIN THAT HE WAS HAPPY WITH LEG LENGTH AND OFFSET, BUT WAS NOT HAPPY WITH STABILITY AS THE PATIENT HAD DISLOCATED. THE SURGEON EXCHANGED THE FEMORAL HEAD FOR A +8MM HEAD (PRIMARY WAS +0), CHECKED WITH X-RAY AND PERFORMED STABILITY CHECK BEFORE CLOSING. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. 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 15870795 ↗
• 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 AND UNEXPLAINED PAIN 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; Pain

  MAUDE report 15734628 ↗
• 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) 2020 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH SIMILAR DEVICES. THIS INFORMATION WAS PROVIDED BY THE (B)(6) 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.

  Patient problems: Joint Dislocation

  MAUDE report 15733788 ↗
• 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 OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2017. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A COMPETITORS ONE. 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 15731222 ↗
• MalfunctionSep 22, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE OXINIUM FEMORAL HEAD 12/14 TAPER 32MM +0 WAS OPENED IN THE STERILE FIELD AND WHEN THE SURGEON PUT IT IN THE STEM, THE ASSISTANT NOTICED A SCRATCH THEREFORE ANOTHER FEMORAL HEAD WAS OPENED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466387 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A HEMATOMA. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE OXINIUM FEM HD 12/14 32MM +0 AND R3 20 DEG XLPE ACET LNR 32 MM X 50 MM WERE EXPLANTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 15349243 ↗
• InjuryJun 13, 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, FIFTY FOUR (54) WERE INDICATED FOR A POSTOPERATIVE DISLOCATION OR SUBULXATION INSTANCE. 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: Joint Dislocation; Subluxation

  MAUDE report 14682475 ↗
• InjuryMay 12, 2022Adverse 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) 2022, THE PATIENT HAD A LEG LENGTH DISCREPANCY. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE ANTHOLOGY SO POR PL HA SZ 8 AND THE OXINIUM FEM HD 12/14 32MM +0. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Unequal Limb Length

  MAUDE report 14376072 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021, ALONG WITH A WASHOUT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13153113 ↗
• InjuryNov 17, 2021Migration; Migration

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2021, A (B)(6) FEMALE PRESENTED WITH INCREASING RIGHT HIP REGION PAIN ON MOBILIZATION. NO REPORTS OF TRIP, FALLS OR INCIDENTS. CT AND X-RAY SHOWED A FRACTURE OF THE PROXIMAL FEMUR WITH SIGNIFICANT STEM SUBSIDENCE. PATIENT MEDICAL HISTORY INCLUDES OVERWEIGHT (BMI NOT KNOWN). ORIGINAL POLARSTEM SUBSIDED, SO THE STEM AND THE HEAD WERE REMOVED. ORIF WAS COMPLETED AND A REDAPT STEM AND A NEW HEAD WERE IMPLANTED ON (B)(6) 2021. THE ORIGINAL SHELL AND LINER WERE RETAINED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN DUE TO HOSPITAL CONFIDENTIALITY POLICY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12828853 ↗
• InjuryNov 9, 2021Degraded; Device Damaged by Another Device; Degraded; Device Damaged by Another Device

  (B)(6). IT WAS REPORTED THAT, APPROXIMATELY A MONTH AFTER A THA HAD BEEN PERFORMED ON THE PATIENT'S RIGHT HIP ON (B)(6) 2020, THE PATIENT EXPERIENCED A SUDDEN ONSET OF A GRINDING SENSATION IN HER RIGHT HIP. FURTHER RADIOGRAPHS REVEALED WHAT APPEARED TO BE A SPUN OUT OF APPROXIMATELY 90 DEGREES ANTERIORLY OF THE R3 0 DEG XLPE ACET LNR 32MM X 50MM ORIGINALLY IMPLANTED. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2020, IN WHICH THE R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM +0 WERE REPLACED. . INTRAOPERATIVELY, THE OXINIUM FEM HD 12/14 32MM +0 WAS NOTICED TO HAVE SIGNIFICANT SURFACE WEAR, SINCE IT WAS ARTICULATING DIRECTLY WITH THE TITANIUM SHELL. UPON REMOVAL AND INSPECTION OF THE R3 0 DEG XLPE ACET LNR 32MM X 50MM, A SINGLE BROKEN OFF PIECE WAS NOTICED TO BE RETAINED IN THE ACETABULAR CUP. THE PATIENT RECOVERED UNEVENTFULLY AND TRANSFERRED STABLE TO PACU. DUE TO REVISION SURGERY, THE PATIENT CURRENTLY EXPERIENCES SOME LEVEL OF PAIN AND DECREASED RANGE OF MOTION DAILY. PATIENT IS CURRENTLY STABLE.

  Patient problems: Discomfort; Failure of Implant; Inflammation; Joint Dislocation; Loss of Range of Motion; Pain

  MAUDE report 12779742 ↗
• InjurySep 14, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED, THE R3 0 DEG XLPE ACET LNR 32MM X 50MM BROKE AND BECOME DISLODGED. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2020, IN WHICH THE R3 0 DEG XLPE ACET LNR 32MM X 50MM AND OXINIUM FEM HD 12/14 32MM +0 WERE REPLACED. DUE TO REVISION SURGERY, THE PATIENT CURRENTLY EXPERIENCES SOME LEVEL OF PAIN AND DECREASED RANGE OF MOTION DAILY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12471534 ↗

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.