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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71441137
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/26/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during tka a pin stuck in the cutting block.It is unknown how the procedure finished.Unknown if occurred a surgical delay.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name
GII MI IN SLT 3 MO TI CU BL RT
Common Device Name
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10563856
Report Number1020279-2020-04754
Device Sequence Number2779395
Product Code HRY
UDI-Device Identifier03596010484093
UDI-Public03596010484093
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K121393
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number71441137
Device Catalogue Number71441137
Device Lot Number16EM00190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2020
Initial Date Received by Manufacturer 08/26/2020
Supplement Date Received by Manufacturer10/29/2020
Initial Report FDA Received Date09/21/2020
Supplement Report FDA Received Date10/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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