NA 71303204Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010194190), received between Jun 25, 2018 and Feb 2, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, AFTER UNDERGOING A LEFT THR REVISION SURGERY ON (B)(6) 2017 DUE TO DISSOCIATION OF LINER (UNKNOWN BRAND), THE PATIENT EXPERIENCED DISLOCATION/SUBLUXATION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A SECOND REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE FEMORAL HEAD AND LINER WERE REMOVED AND REPLACED WITH SMITH+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 THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 16283016 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR WAS PERFORMED ON (B)(6) 2014 DUE TO OSTEOARTHRITIS, THE PATIENT EXPERIENCED UNEXPLAINED PAIN. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE MODULAR HEAD WAS REMOVED AND REPLACED WITH ANOTHER 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: Pain

  MAUDE report 16135017 ↗
• 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 16040482 ↗
• InjuryNov 15, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2017 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) 2019. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH A SMITH AND NEPHEW COMPONENT. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE (B)(6), 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 15799124 ↗
• 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 MODULAR FEMORAL 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 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 15697315 ↗
• InjuryOct 29, 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) 2019 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SMITH AND NEPHEW BEARING 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 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 15697310 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE LITERATURE REVIEW "METALLOSIS AFTER HIP ARTHROPLASTY: TWO CASE REPORTS", 1 PATIENT SUFFERED 2 DISLOCATIONS (UNKNOWN IN WHICH IMPLANTS) THE FIRST 8 YEARS LATER AND THE SECOND 9 YEARS AND 7 MONTHS LATER OF THE RIGHT INITIAL R3-THA SURGERY. AT THE TIME OF THE SECOND DISLOCATION, RADIOGRAPHS SUGGESTED RADIOLUCENCY IN THE GREATER TROCHANTER AND SOFT TISSUE DARKENING AND MINERALIZATION ANTERIOR TO THE JOINT. MRI IMAGING REVEALED COMPLEX MULTILOCULATED FLUID COLLECTIONS SUGGESTING AN EXTENSIVE PSEUDOTUMOR. SIX WEEKS AFTER CONFIRMATION OF PSEUDOTUMOR, THE PATIENT UNDERWENT COMPLETE EXCISION OF THE PSEUDOTUMOR FOLLOWED BY REVISION OF RIGHT R3-THA AND RECONSTRUCTION OF THE ABDUCTOR MECHANISM. DURING REVISION SURGERY, TRUNNION WEAR WITH BLACK DEPOSITS ON THE FEMORAL NECK WAS OBSERVED. AT 6 WEEKS FOLLOW-UP PATIENT WAS RECOVERING WELL. THERE'S NO MORE AVAILABLE INFO.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 14520062 ↗
• InjuryMay 20, 2022Biocompatibility; Biocompatibility

  "IT WAS REPORTED THAT ON LITERATURE REVIEW ""METALLOSIS FOLLOWING HIP ARTHROPLASTY: TWO CASE REPORTS"", ONE PATIENT HAD A PRIMARY RIGHT HIP THA SURGERY WITH A R3 ACETABULAR SHELL, R3 POLY LINER, SYNERGY STEM AND COCR FEMORAL HEAD. 8 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT SUFFERED FROM A DISLOCATION AND ONE YEAR LATER, THE PATIENT SUSTAINED A SECOND DISLOCATION. THE PATIENT EXHIBITED SIGNS OF METALLOSIS AND UNDERWENT A REVISION SURGERY TO TREAT THE ADVERSE EVENT. AT 6 WEEKS FOLLOW-UP, THE PATIENT WAS RECOVERING WELL.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 14450385 ↗
• InjuryOct 27, 2021Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON 1999, THE PATIENT EXPERIENCED AN EXCHANGE OF THE LINER IN 2013 DUE TO POLYETHYLENE WEAR. THE ORIGINAL HEAD WAS A COBALT CHROME TAPER 26MM +4. THE ORIGINAL CUP WAS A REFLECTION 50MM E LINER. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY IN WHICH THE 32MM LINER SIZE E WAS INSERTED WITH A 32MM OD COBALT CHROME HEAD +4MMS. IN A REVISION SURGERY PERFORMED ON 2013.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12707944 ↗
• InjuryOct 11, 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 FALL AND EXPERIENCED A FEMUR FRACTURE. THIS ADVERSE EVENT LED TO A REVISION SURGERY PERFORMED ON (B)(6) 2021 IN WHICH A POLARSTEM STEM STD TI/HA 0 NON-CEM AND A COCR 12/14 FEM HEAD 32 + 4 WERE EXPLANTED AND ACCORD TROCHANTERIC GRIP PLATE WAS IMPLANTED WITH CABLES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 12611743 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR REVISION SURGERY HAD BEEN PERFORMED ON 18-MAY-2017 WITH EXTREME PAIN, DIFFICULTY FOR WALKING, WEIGHT LOSS, LETHARGIA, AND ANAEMIA DIAGNOSIS, THE PATIENT EXPERIENCED UNEXPLAINED PAIN AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A SECOND REVISION SURGERY ON 21-JUL-2020. ACCORDING TO THE REPORT CONTENTS, THE ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH 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 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: Pain

  MAUDE report 10082877 ↗
• InjuryJan 7, 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 PAIN AND ELEVATED METAL ION LEVELS. SUPECTED TRUNIONOSIS OF A COCR FEMORAL HEAD ON A TITANIUM ALLOY UNCEMENTED POLARSTEM.

  Patient problems: Pain

  MAUDE report 9558084 ↗
• InjuryDec 30, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO A SUSPECTED TRUNIONOSIS.

  Patient problems: Injury

  MAUDE report 9532350 ↗
• InjuryMar 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE RECURRENT DISLOCATIONS. FEMORAL HEAD WAS REMOVED. NO DELAY REPORTED AND NO BACKUP DEVICE WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 8400270 ↗
• InjuryJun 25, 2018Device 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 THE PATIENT WAS READMITTED TO HOSPITAL POST OP FOLLOWING PAIN. NOTES INDICATED THAT IT MAY HAVE DISLOCATED. THE ACETABULAR AND FEMORAL COMPONENT WERE WELL FIXED. THE LINER AND CUP WERE REMOVED AND REPLACED WITH A SUBSEQUENT COMPANIES IMPLANTS. THE HEAD WAS ALSO REMOVED AND EXCHANGED, MULTIPLE SAMPLES WERE COLLECTED AND SENT TO PATHOLOGY.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7632990 ↗

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.