POLARCUP 75100514Recalls & reported problems
Smith & Nephew, Inc. · BASIC CASE I POLARCUP 10 · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996118971), received between May 20, 2020 and May 20, 2020 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Joint Dislocation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITERATURE CASE "DUAL-MOBILITY CUPS IN REVISION ACETABULAR RECONSTRUCTIONS: SHORT-TERM OUTCOMES IN HIGH-RISK PATIENTS FOR INSTABILITY". AUTHOR: GOKSEL DIKMEN ET AL., THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE PERFORMANCE OF DUAL-MOBILITY (DM) CUP SYSTEMS FOR REVISION TOTAL HIP ARTHROPLASTY (RTHA) IN PATIENTS WHO HAD HIGH RISK FOR INSTABILITY. 30 PATIENTS UNDERWENT 34 HIPS RTHA WITH DM CUPS. IT WAS DOCUMENTED ON THE PAPER THAT 2 PATIENTS UNDERWENT RE-REVISIONS DUE TO ASEPTIC LOOSENING. THE REASON OF ASEPTIC LOOSENING WAS THE MIGRATION OF THE CEMENTED ACETABULAR CUPS FROM THE ACETABULUM IN PATIENTS WITH SEVERE HIP ABDUCTOR INSUFFICIENCY.
Patient problems: Joint Dislocation
MAUDE report 10077642 ↗InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LITERATURE CASE "DUAL-MOBILITY CUPS IN REVISION ACETABULAR RECONSTRUCTIONS: SHORT-TERM OUTCOMES IN HIGH-RISK PATIENTS FOR INSTABILITY". AUTHOR: GOKSEL DIKMEN ET AL., THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE PERFORMANCE OF DUAL-MOBILITY (DM) CUP SYSTEMS FOR REVISION TOTAL HIP ARTHROPLASTY (RTHA) IN PATIENTS WHO HAD HIGH RISK FOR INSTABILITY. 30 PATIENTS UNDERWENT 34 HIPS RTHA WITH DM CUPS. IT WAS DOCUMENTED ON THE PAPER THAT 2 PATIENTS UNDERWENT RE-REVISIONS DUE TO ASEPTIC LOOSENING. THE REASON OF ASEPTIC LOOSENING WAS THE MIGRATION OF THE CEMENTED ACETABULAR CUPS FROM THE ACETABULUM IN PATIENTS WITH SEVERE HIP ABDUCTOR INSUFFICIENCY.
Patient problems: Joint Dislocation
MAUDE report 10077614 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.