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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 13MM SZ 4-5 LT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. LEGION HK GD MOTION ISRT 13MM SZ 4-5 LT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71423354
Device Problem Failure to Align (2522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, during tkr surgery, surgeon was unable to align the screw with the legion hk gd motion isrt 13 mm sz 4-5 lt and the legion hk tibial base sz 5 lt for a successful insertion. Surgery was resumed, after a 40 minutes delay, with the same devices. It is unknown the current health status of the patient.
 
Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. A review of complaint history did not reveal additional complaints for the listed batch. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance. Based on this investigation, the need for corrective action is not indicated. Without the return of the actual product involved, our investigation could not proceed. Should the device or additional information be received, the complaint will be reopened. No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary. We consider this investigation closed.
 
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Brand NameLEGION HK GD MOTION ISRT 13MM SZ 4-5 LT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12485493
MDR Text Key271890927
Report Number1020279-2021-06928
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71423354
Device Catalogue Number71423354
Device Lot Number12MM10569
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No

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