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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,

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SMITH & NEPHEW ORTHOPAEDICS AG RT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, Back to Search Results
Catalog Number 71420574
Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/26/2020
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that, revision surgery was performed one year after primary procedure due to ptg infection. The information about which device(s) caused the infection was not initially provided.
 
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Brand NameRT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM)
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau TN CH-50 00
SZ CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau TN CH-50 00
SZ CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11099933
MDR Text Key224521742
Report Number9613369-2020-00278
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K023667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71420574
Device Lot NumberI1822120
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 Received01/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/07/2018
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: 12/31/2020 Patient Sequence Number: 1
Treatment
71420574/GNS II RESURF PAT 29MM/19AM19414; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV
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