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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED

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SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED Back to Search Results
Model Number 71423358
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case(b)(4).
 
Event Description
It was reported that, during a tka surgery, when locking the legion hk gd motion isrt 18mm sz 4-5 lt on the posterior, screw broke in half and the bottom half got stuck in the baseplate. Surgery was finished, after a delay of 30 minutes or less and with a change in the surgical technique. No harm to the patient or further complications reported.
 
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Brand NameLEGION HK GD MOTION ISRT 18MM SZ 4-5 LT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED
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 Key14068479
MDR Text Key288994267
Report Number1020279-2022-01721
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71423358
Device Catalogue Number71423358
Device Lot Number18AM14224
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2018
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: 04/09/2022 Patient Sequence Number: 1
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