POLARSTEM 75102077Recalls & reported problems

Smith & Nephew, Inc. · POLARSTEM VALGUS NON-CEMENTED WITH Ti/HA 5 · 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 07611996142372), received between May 22, 2025 and May 22, 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

Foreign Body Reaction1
Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A THR SURGERY HAD PERFORMED. ON (B)(6) 2024, PATIENT EXPERIENCED AN ALLERGIC REACTION AND SYSTEMIC INFLAMMATION (HIGH INFLAMMATORY MARKERS). IT HAS BEEN TREATED WITH DAILY PREDNISONE. ALTHOUGH, THE PROTHESIS IS FUNCTIONING WELL AS THE X-RAYS FROM (B)(6) 2024 SHOWED THAT THERE WAS NO LOOSENING OF THE COMPONENTS. PATIENT HAS HAD SEVERAL ALLERGIES TESTS DURING WHICH TESTED POSITIVE FOR ALL COMPONENTS. IN ADDITION, LTT BLOOD TEST WAS DONE WITH TITANIUM OXIDE, AND IT WAS ALSO POSITIVE. THE PATIENT'S OVERALL HEALTH STATUS IS STABLE. A REVISION SURGERY MAY BE REQUIRED TO ADDRESS THE ADVERSE EVENT; HOWEVER, IT IS YET TO BE SCHEDULED.
Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction
MAUDE report 22072407 ↗

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	`07611996142372`
Brand	POLARSTEM
Model	75102077
Company	Smith & Nephew, Inc.
Product code	LZO · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Class	Class 2
FDA submission	K143739, K211176
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Nov 28, 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, metal/ceramic/polymer, cemented or non-porous, uncemented devices

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551 reports
PINNACLE ALTRX 1221-36-052
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481 reports
BIOLOX DELTA 1365-32-320
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1 death314 reports
BIOLOX DELTA 1365-36-720
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
1 death189 reports
DJO SURGICAL 400-03-362
Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
187 reports
Anthology 71365705
Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
176 reports
BIOLOX DELTA 1365-40-710
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
170 reports
PINNACLE GRIPTION 1217-32-054
Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
169 reports

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented 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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