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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.
 
Manufacturer Narrative
Additional information received by the customer has identified that this event has been already reported under 9613369-2020-00189.The new information confirms that this is a duplicate complaint, therefore, if further details are provided in future confirming the opposite, our files will be updated accordingly and a further report will be submitted outlining both events details and our investigations performed.
 
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Brand Name
UNKNOWN RT-PLUS OR RT-PLUS MODULAR IMPLANT
Type of Device
PROSTHESIS,KNEE,FEMOROTIBIAL,CONSTRAINED,CEMENTED,METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ  CH-5000
MDR Report Key10616164
MDR Text Key209545751
Report Number9613369-2020-00192
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
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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