POLARSTEM 75004647Recalls & reported problems
Smith & Nephew, Inc. · POLARSTEM DETACHABLE RASP 6 · Class 2
- 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 07611996097542), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 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, AFTER REAMING WITH THE POLARSTEM DETACHABLE RASP 5 AND IMPLANTING THE SIZE 5 STEM, THE PATIENT EXPERIENCED A PROXIMAL FEMUR CRACK, REQUIRING THE PLACEMENT OF A CABLE AROUND THE FRACTURE SITE. SUBSEQUENTLY, AFTER REAMING WITH THE POLARSTEM DETACHABLE RASP 6 AND IMPLANTING THE SIZE 6 STEM, THE PATIENT EXPERIENCED A DISTAL FEMUR FRACTURE, REQUIRING THE USE OF A CABLE TO SECURE THE FRACTURE. BOTH RASPS WERE FOUND TO BE DULL, AND THEY WERE COMPACTING INSTEAD OF CUTTING AS INTENDED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICES. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 19153980 ↗
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.