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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR REAMER GUIDE PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT Back to Search Results
Model Number 75102205
Device Problem Break
Event Date 08/02/2017
Event Type  Injury  
Event Description

Piece broken off, do not have that piece to return. The piece was retrieved but was lost in the decontamination process in spd. [nil, (b)(6) 2017] confirmation that the spring was removed from the wound and following statement received: "the surgeon reamed the calcar then could not disengage the neck. It broke while trying to dislodge it from the broach. The calcar reaming process in the polar stem is cumbersome. ".

 
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Brand NamePOLARSTEM COLLAR REAMER GUIDE
Type of DevicePROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
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 Key10180009
Report Number9613369-2020-00121
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
1 Patient Was Involved in the Event
Date FDA Received06/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number75102205
Device Catalogue Number75102205
Device LOT NumberA57539
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/22/2020 Patient Sequence Number: 1
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