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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT WITH TI/HA 4 NON-CEM PROSTHESIS,HIP,HEMI-,FEMORAL,METAL/POLY,CEMENTED-UNCEMENT

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SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT WITH TI/HA 4 NON-CEM PROSTHESIS,HIP,HEMI-,FEMORAL,METAL/POLY,CEMENTED-UNCEMENT Back to Search Results
Catalog Number 75002081
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pulmonary Embolism (1498)
Event Date 05/01/2009
Event Type  Injury  
Event Description
It was reported that, 3 months after the patient underwent a primary left hip replacement on (b)(6) 2009 due to hip arthritis, the patient suffered from a lung embolism. The adverse event was determined as related to the procedure. It is unknown if/how this adverse event was treated. The outcome of the patient was not reported.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
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Brand NamePOLARSTEM STEM LAT WITH TI/HA 4 NON-CEM
Type of DevicePROSTHESIS,HIP,HEMI-,FEMORAL,METAL/POLY,CEMENTED-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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13087871
MDR Text Key282777362
Report Number9613369-2021-00430
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/23/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/02/2012
Device Catalogue Number75002081
Device Lot NumberJ380M10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/18/2022
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

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