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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LATERAL WITH TI/HA 2 NON-CEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LATERAL WITH TI/HA 2 NON-CEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED Back to Search Results
Model Number 11000338
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 01/29/2018
Event Type  Injury  
Event Description

User report (b)(4) reported through ansm: revision surgery due to fracture of the polarstem stem. Stem was exchanged. The patient fell down. Patient is overweight.

 
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Brand NamePOLARSTEM STEM LATERAL WITH TI/HA 2 NON-CEM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
oberneuhofstrasse 10d
baar 6340
SZ 6340
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau 5001
SZ 5001
Manufacturer Contact
sarah freestone
MDR Report Key7312603
MDR Text Key101466836
Report Number9613369-2018-00012
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK130728
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/07/2014
Device MODEL Number11000338
Device Catalogue Number75002079
Device LOT NumberKM061M41
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/07/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/05/2018 Patient Sequence Number: 1
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