POLARSTEM 75004644Recalls & reported problems
Smith & Nephew, Inc. · POLARSTEM DETACHABLE RASP 3 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996097511), received between Nov 18, 2020 and Apr 22, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K123598); 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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Material Deformation1
Patient problems
- Bone Fracture(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A THR SURGERY, THE PATIENT EXPERIENCED A FRACTURE OF THE FEMUR DUE TO THE DULLNESS OF ONE (1) POLARSTEM DETACHABLE RASP 01, WHICH FAILED TO PROPERLY BROACH THE BONE DUE TO COMPACTING. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 19154065 ↗MalfunctionNov 18, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE SURGEON TRIED TO REMOVE THE POLAR-STEM DETACHABLE RASP 3, THE HANDLE DID NOT FIT THE DEVICE WELL. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10862820 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.
- Z-0730-2019 · Jan 7, 2019 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.