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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE

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SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE Back to Search Results
Catalog Number UNKN01200215
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 04/27/2021
Event Type  Injury  
Event Description
It was reported that, after a tka, the patient presented with painful from initial surgery on (b)(6) 2018. A revision surgery was performed on (b)(6) 2021, and was noted that the lgn cr high flex xlpe sz 7-8 9mm insert was pitted and the tibial baseplate was loose. The current health status of patient is unknown.
 
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Brand NameUNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE
Type of DeviceUNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE
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 Key11832596
MDR Text Key251114093
Report Number1020279-2021-04357
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKN01200215
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 Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/17/2021 Patient Sequence Number: 1
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