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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN RT-PLUS OR RT-PLUS MODULAR IMPLANT PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAINED,CEMENTED,METAL/POLYMER
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SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN RT-PLUS OR RT-PLUS MODULAR IMPLANT PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAINED,CEMENTED,METAL/POLYMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 09/02/2020
Event Type  Injury  
Event Description
It was reported that 5 patients were treated using smith and nephew rt-plus hinge prosthesis and 1 patient presented local hematoma which led to rehabilitation temporization and imposed rest, elastic bandages and cryotherapy. One of them remitted was evacuated.
 
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Brand NameUNKNOWN RT-PLUS OR RT-PLUS MODULAR IMPLANT
Type of DevicePROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAINED,CEMENTED,METAL/POLYMER
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
oberneuhofstrasse 10d
baar 
SZ  
MDR Report Key10611029
MDR Text Key209340168
Report Number9613369-2020-00189
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K023667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? No
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: 09/30/2020 Patient Sequence Number: 1
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