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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. GII DISHED INS SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number 71420778
Medical Device Problem Code Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a tkr, the genesis ii dished articular insert in the size 5 was not able to be locked in the tibial baseplate.There was a delay of 30 minutes or less and the procedure was finished using a smith & nephew back up.Patient was not harmed.
 
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Brand Name
GII DISHED INS SZ 5-6 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key11901511
Report Number1020279-2021-04746
Device Sequence Number3754901
Product Code JWH
UDI-Device Identifier03596010209382
UDI-Public03596010209382
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (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) 08/16/2021
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 Number71420778
Device Catalogue Number71420778
Device Lot Number20LT44221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Initial Date Received by Manufacturer 05/12/2021
Supplement Date Received by Manufacturer08/10/2021
Initial Report FDA Received Date05/28/2021
Supplement Report FDA Received Date08/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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