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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 71932636
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 10/30/2014
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient needed revision surgery due to arthrofibrosis.
 
Additional Manufacturer Narrative
Acknowledgment and first request letter was sent and attached.(b)(4).
 
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Brand Name
GEN II 7.5MM RESUR PAT 32MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7070748
Report Number1020279-2017-01161
Device Sequence Number16536977
Product Code JWH
UDI-Device Identifier00885556056721
UDI-Public00885556056721
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source study,user facility
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/19/2018
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 Expiration Date04/20/2024
Device Catalogue Number71932636
Device Lot Number14DM17400
Initial Date Received by Manufacturer 11/16/2017
Supplement Date Received by Manufacturer11/16/2017
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date02/19/2018
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 Age54 YR
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