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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY II BCS KNEE INSERT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH & NEPHEW, INC. UNKN JOURNEY II BCS KNEE INSERT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number UNKN01200312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)
Event Date 12/10/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, after a tka surgery had been performed on (b)(6) 2017, the patient experienced fever, swelling and an infection. This adverse event was solved by a revision surgery on (b)(6) 2021. Current health status of patient is unknown.
 
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Brand NameUNKN JOURNEY II BCS KNEE INSERT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13111545
MDR Text Key282917162
Report Number1020279-2021-08951
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKN01200312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/27/2022
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

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