POLARSTEM 75102072Recalls & reported problems

Smith & Nephew, Inc. · POLARSTEM VALGUS NON-CEMENTED WITH Ti/HA 0 · Class 2 · Implant

All models of POLARSTEM (63)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996142327), received between Aug 28, 2025 and Aug 28, 2025 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K143739, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Periprosthetic fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryAug 28, 2025Adverse 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) 2025, THE PATIENT EXPERIENCED A PROXIMAL FEMUR FRACTURE WHICH WAS FOUND ON AN X-RAY PERFORMED ON (B)(6) 2025, THE NEXT DAY POST-OPERATION. THE REASON FOR THE FRACTURE IS UNKNOWN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) POLARSTEM VALGUS TI/HA 0 , ONE (1) OXINIUM FEM HD 12/14 22 MM +0, AND ONE (1) OR3O DM XLPE INSERT 22/36 WERE EXPLANTED. PATIENT IS WELL, HAS GONE HOME AND IS MOBILIZING WELL
Patient problems: Periprosthetic fracture
MAUDE report 22910265 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739, 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-2827-2020 · Jul 22, 2020 · Open, Classified
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the

Device details

UDI-DI	`07611996142327`
Brand	POLARSTEM
Model	75102072
Company	Smith & Nephew, Inc.
Product code	MEH · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Class	Class 2
FDA submission	K143739, K211176
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 15, 2025

Device type (GMDN): Coated hip femur prosthesis, modular

A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices

Novation 130-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls156 reports
Novation 130-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls79 reports
CORAIL 3L92511
Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
158 reports
Acumatch A Series 138-36-29
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
3 recalls1 report
Novation 136-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls43 reports
Novation 130-32-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls33 reports
Novation 132-32-51
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls26 reports
Novation 136-36-53
Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
2 recalls22 reports

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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