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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE PROSTHESIS,HIP,SEMICNSTRIED,METAL/CERAMIC/POLYMER,CEMENTED,UNCMNTD

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE PROSTHESIS,HIP,SEMICNSTRIED,METAL/CERAMIC/POLYMER,CEMENTED,UNCMNTD Back to Search Results
Model Number 75102205
Device Problem Break
Event Date 02/10/2020
Event Type  Malfunction  
Event Description

It was reported that the device failed during procedure. It was confirmed, in an additional information, that the device broke, however no pieces fell inside the wound. All fragments were disposed.

 
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Brand NamePOLARSTEM COLLAR REAMER GUIDE
Type of DevicePROSTHESIS,HIP,SEMICNSTRIED,METAL/CERAMIC/POLYMER,CEMENTED,UNCMNTD
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
baar 06340
SZ  06340
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH500 0
SZ  CH5000
Manufacturer Contact
sarah freestone
oberneuhofstrasse 10d
baar  06340
  06340
0447940038
MDR Report Key10200775
Report Number9613369-2020-00132
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number75102205
Device Catalogue Number75102205
Device LOT NumberA57539
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/02/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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