POLARSTEM 75100476Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996118674), received between Mar 6, 2019 and Jan 27, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K130728, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT LEFT SURGERY PERFORMED ON (B)(6) 2012 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE MODULAR HEAD WAS EXCHANGED 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 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

  MAUDE report 16258187 ↗
• InjuryJan 27, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT LEFT SURGERY PERFORMED ON (B)(6) 2013 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED PERI-PROSTHETIC FRACTURE OF THE STEM THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE FEMORAL STEM, MODULAR HEAD AND FEMORAL CEMENT WERE EXCHANGED WITH COMPETITOR 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

  MAUDE report 16258034 ↗
• InjuryJan 19, 2023Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2017 TO ADDRESS AVASCULAR NECROSIS (AVN), THE PATIENT SUSTAINED LOOSENING OF THE STEM AND INFECTION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2020. DURING THIS PROCEDURE, THE FEMORAL STEM, ACETABULAR CUP, MODULAR HEAD, ACETABULAR LINER WERE EXCHANGED 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 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: Failure of Implant; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 16209478 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR HAVE BEEN PERFORMED ON (B)(6) 2022, WHEN THE PATIENT WAS CHOPPING WOOD, TRIPPED AND FELL HEAVILY ON HIS OPERATIVE SIDE CAUSING A PERI-PROSTHETIC FRACTURE 5/52 POST DAA SURGERY. AN REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THE ADVERSE EVENT USING ORIF, CABLING WITH TROCHANTERIC PLATE/CABLES, REDAPT STEM, OX HEAD. THIS WAS A REVISION SURGERY, NOT ATTRIBUTED TO PROSTHESIS. FURTHER PATIENT INFORMATION IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hip Fracture

  MAUDE report 14807234 ↗
• InjuryMar 4, 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 PERI PROSTHETIC FRACTURE. THE PATIENT FRACTURED THE FEMUR AROUND THE STEM AFTER FALLING OFF A BIKE. DURING THE PROCEDURE, THE STEM AND THE FEMORAL HEAD WERE REPLACED AND ACCORD CABLES WERE PLACED AROUND FEMUR SHAFT TO FIX THE FRACTURE. PRIMARY SURGERY WAS A THR PERFORMED ON (B)(6) 2014.

  Patient problems: Hip Fracture

  MAUDE report 11409072 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY HIP ARTHROPLASTY WAS PERFORMED IN (B)(6) 2020. HIP REVISION HAD TO BE PERFORMED DUE TO A PROXIMAL FEMORAL FRACTURE WHICH LIKELY OCCURRED AT TIME OF PRIMARY SURGERY AS PER SURGEON. THE DR. OPENED PREVIOUS INCISION VIA A DIRECT ANTERIOR APPROACH. DISLOCATED HIP. PRIMARY STEM AND HEAD REMOVED WITH PUNCH. DR THEN PREPARED THE FEMUR AS PER A STANDARD SURGICAL TECHNIQUE. SIZE 2 LATERAL POLAR UNCEMENTED STEM INSERTED. SIZE 36 -4 OXINIUM HEAD ALSO INSERTED. INTRA-OPERATIVE X-RAY ATTENDED.

  Patient problems: Hip Fracture

  MAUDE report 11058847 ↗
• MalfunctionDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SIZE 3 STEM WAS EXTREMELY EASY TO KNOCK IN. SURGEON HAD TO UPSIZE TO SIZE 4 STEM WHICH MATCHED THE TRIAL MORE CLOSELY. DELAY NO GREATER THAN 30 MINUTES WAS RECORDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511508 ↗
• InjuryMar 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  DR (B)(6) PERFORMED A HEMIARTHROPLASTY ON HIS PATIENT USING THE ABOVE IMPLANTS. ONCE THE HIP WAS REDUCED HE NOTED THAT THERE WAS NO MOVEMENT BETWEEN THE 22MM FEMORAL HEAD AND THE TANDEM SHELL, EFFECTIVELY NEGATING THE BENEFIT OF USING A BI-POLAR CONSTRUCT. EVEN ON MOVING THE ARTICULATING SURFACE BY HAND THE COMPONENTS WERE VERY STIFF AND RESISTANT TO FREE MOVEMENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 8394723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130728, 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-3100-2017 · Jul 24, 2017 · Terminated
  smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction w