NA 71303200Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010194176), received between Sep 27, 2018 and Jan 10, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K211176, K963509); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR WAS PERFORMED ON (B)(6) 2018 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS/IMPAIRMENTS. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED 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: Insufficient Information

  MAUDE report 16135014 ↗
• InjuryDec 22, 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) 2019 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 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 16039464 ↗
• InjuryDec 22, 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 (B)(6) 2018. 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 16038083 ↗
• InjuryNov 14, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH 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 AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 15794215 ↗
• InjuryNov 14, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A LEFT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENTS. 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 THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 15789021 ↗
• InjuryOct 29, 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) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2019. DURING THIS PROCEDURE, THE ACETABULAR CUP, ACETABULAR LINER AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW ACETABULAR CONSTRUCT. 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 THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15697302 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER LEFT THR PERFORMED ON (B)(6) 2021, THE PATIENT PRESENTED AN INFECTION WITH PREVIOUS PELVIC FRACTURE. THIS WAS ADDRESSED VIA REVISIONS SURGERY ON (B)(6) 2022. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Hip Fracture; Unspecified Infection

  MAUDE report 13559744 ↗
• InjuryDec 23, 2021Adverse 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 PRESENTED AN INFECTION, SO A FIRST STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE AND REPLACE AN UNKNOWN REFLECTION LINER ((B)(4)), A SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEM SZ 3 ((B)(4)), A COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0 ((B)(4)) AND A REFLECTION THREE HOLE SHELL SIZE 52MM ((B)(4)). CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13080920 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR HAD BEEN PERFORMED ON (B)(6) 2018 TO ADDRESS A PREVIOUS HIP SURGERY-NON TRAUMA RELATED, THE PATIENT EXPERIENCED A PERI-PROSTHETIC FRACTURE AND DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 WHERE THE FEMORAL STEM AND THE MODULAR HEAD WERE EXPLANTED AND REPLACED WITH SIMILAR SMITH AND NEPHEW 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 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: Bone Fracture(s); Failure of Implant; Joint Dislocation

  MAUDE report 12239296 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A HIP REPLACEMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A TWO REVISION SURGERIES, THE LATEST ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12046408 ↗
• InjuryMay 13, 2021Adverse 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) 2021, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE R3 20 DEG XLPE ACET LNR 32MM X 50MM WAS EXPLANTED. DURING WASHOUT + CALCIUM SULPHATE BEADS PROCEDURE THE R3 3 HOLE HA CTD ACET SHELL 50MM APPEARED LOOSE, WITH OSTEOLYSIS ALSO SEEN SUPEROLATERAL IN THE ACETABULUM/ILIUM. THE COCR 12/14 FEM HEAD 32 + 0 AND TWO UNIDENTIFIED SCREWS WERE ALSO EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 11821300 ↗
• InjuryMar 20, 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 ON (B)(6) 2020 DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9860620 ↗
• InjuryDec 26, 2019Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO MULTIPLE DISLOCATIONS. LINER AND HEAD WERE EXCHANGED. IN ADDITION TO THIS THE PATIENT PRESENTED 5 DISLOCATIONS ON THE DATES: (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, (B)(6) 2017 THESE WERE TREATED WITH CLOSED REDUCTIONS. THE DOCTOR SENT A LETTER TO THE PATIENT STATING THAT THE FEMORAL COMPONENT USED ON THE FIRST REVISION SURGERY WAS MISLABELED AND IT WAS A 32MM RATHER THAN A 28MM.

  Patient problems: Joint Dislocation

  MAUDE report 9520218 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION, THE PATIENT HIP WAS PREPPED AND DRAPED JOINT OPENED SPECIMENS TAKEN, THE JOINT GOT LAVAGED AND DEBRIDED INTENSELY. THE FEMORAL HEAD AND POLY LINER WERE REMOVED. THE JOINT LAVAGED AGAIN WITH HYDROGEN PEROXIDE AND MORE SALINE SOLUTION. NEW LINER AND HEAD INSERTED. HIP REDUCED HIP CLOSED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9281475 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS.

  Patient problems: Injury

  MAUDE report 8334092 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS (PAIN) TO REMOVE THE STEM AND CUP FROM THE PATIENT. NO DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 8108722 ↗
• InjurySep 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY DUE TO INFECTION. PATIENT HAD RECENTLY A SECOND REVISION FOR INFECTION ON SAME HIP. UNFORTUNATELY THE PATIENTS INFECTION PROGRESSED LEADING TO TODAY'S 3RD REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 7915553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. 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.