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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 3 NON-CEMENTED PRSTHSS,HIP,HEMI,FEMORAL,METAL/POLYMER,CMNTD OR UNCMNTD

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SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 3 NON-CEMENTED PRSTHSS,HIP,HEMI,FEMORAL,METAL/POLYMER,CMNTD OR UNCMNTD Back to Search Results
Model Number 75002699
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 06/16/2020
Event Type  Injury  
Event Description
It was reported that patient suffered the breakage of the sl-plus standard stem 3 non-cemented. Its is not known how long after primary procedure it happened.
 
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Brand NameSL-PLUS STANDARD STEM 3 NON-CEMENTED
Type of DevicePRSTHSS,HIP,HEMI,FEMORAL,METAL/POLYMER,CMNTD OR UNCMNTD
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
SZ
Manufacturer Contact
sarah freestone
oberneuhofstrasse 10d
baar 
SZ  
0447940038
MDR Report Key10261770
MDR Text Key198495711
Report Number9613369-2020-00140
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
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 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/23/2016
Device Model Number75002699
Device Catalogue Number75002699
Device Lot NumberF0911396
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/25/2009
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: 07/11/2020 Patient Sequence Number: 1
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