POLARCUP 75023345Recalls & reported problems

Smith & Nephew, Inc. · POLARCUP IMPACTOR HANDLE · Class 1

All models of POLARCUP (61)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996112344), received between Oct 14, 2020 and Oct 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Device problems

Break1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

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

MalfunctionOct 14, 2020Break; Break
IT WAS REPORTED THAT DURING A THR PROCEDURE, THE PIN PREVENTING THE FROM THE POLARCUP IMPACTOR HANDLE ROTATING HAS BROKEN OFF OUTSIDE OF THE PATIENT, AND NEEDS TO BE REPLACED. NO PIECES FELL INTO THE PATIENT. PROCEDURE FINISHED WITH AN S+N BACKUP DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10678660 ↗

Device details

UDI-DI	`07611996112344`
Brand	POLARCUP
Model	75023345
Company	Smith & Nephew, Inc.
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Surgical instrument handle, non-torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

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All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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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