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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 3-4 9MM; PROSTHESIS, KNEE,SEMI-CONSTRAINED, CMNTD,PLYMR/MAL/PLYMR
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SMITH & NEPHEW, INC. GII C/R ART INS SZ 3-4 9MM; PROSTHESIS, KNEE,SEMI-CONSTRAINED, CMNTD,PLYMR/MAL/PLYMR Back to Search Results
Model Number 71420490
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 01/20/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a standard poly exchange was performed on a patient with a legion total knee.The initial surgery on this patient was performed in 2008.Upon removal of the insert, it was noticed some posterior wear in the poly.No other complications were reported.
 
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Brand Name
GII C/R ART INS SZ 3-4 9MM
Common Device Name
PROSTHESIS, KNEE,SEMI-CONSTRAINED, CMNTD,PLYMR/MAL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9622385
Report Number1020279-2020-00369
Device Sequence Number2295893
Product Code JWH
UDI-Device Identifier03596010207890
UDI-Public03596010207890
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/19/2021
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? No
Operator of Device Health Professional
Device Model Number71420490
Device Catalogue Number71420490
Initial Date Received by Manufacturer 01/20/2020
Supplement Date Received by Manufacturer07/15/2021
Initial Report FDA Received Date01/23/2020
Supplement Report FDA Received Date07/19/2021
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;
Patient Age61 YR
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