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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 4 NON-CEM PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT Back to Search Results
Catalog Number 75100467
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/03/2020
Event Type  Injury  
Event Description

It was reported that the patient, after a primary hip replacement, sustained a fall. After an x-ray assessment, a peri-prosthetic fracture of the femur, just below lt on the medial side, was confirmed. The primary stem had subsided as a result of being unsupported, as noted in the x-ray. Patient underwent surgery to cable the fracture back together. The stem, head, and liner components were removed.

 
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Brand NamePOLARSTEM STEM STD TI/HA 4 NON-CEM
Type of DevicePROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ  CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ  CH-5000
Manufacturer Contact
sarah freestone
oberneuhofstrasse 10d
baar  06340
  06340
0447940038
MDR Report Key10203637
Report Number9613369-2020-00133
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number75100467
Device LOT NumberB1913815
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
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 Initial

Patient TREATMENT DATA
Date Received: 06/26/2020 Patient Sequence Number: 1
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