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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 3-4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
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SMITH & NEPHEW, INC. GII DISHED INS SZ 3-4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, Back to Search Results
Model Number 71420770
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/08/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was conducted to replace a broken insert, all broken parts were extracted, the patient outcome is unknown.No other complications were reported.
 
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand Name
GII DISHED INS SZ 3-4 13MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10644906
Report Number1020279-2020-05206
Device Sequence Number2555349
Product Code JWH
UDI-Device Identifier03596010209344
UDI-Public03596010209344
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number71420770
Device Catalogue Number71420770
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/09/2020
Supplement Date Received by Manufacturer10/19/2020
Initial Report FDA Received Date10/07/2020
Supplement Report FDA Received Date11/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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