Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II RESURF PATELLA 38MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. GEN II RESURF PATELLA 38MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 71926225
Medical Device Problem Code Physical Resistance/Sticking (4012)
Health Effect - Clinical Code Injury (2348)
Date of Event 08/01/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient was diagnosed with left knee stiffness.The event was resolved via manipulation under anesthesia.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GEN II RESURF PATELLA 38MM
Common Device Name
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9900959
Report Number1020279-2020-01062
Device Sequence Number2827910
Product Code JWH
UDI-Device Identifier00885556043998
UDI-Public00885556043998
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K951987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/01/2020
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? No
Operator of Device Health Professional
Device Model Number71926225
Device Catalogue Number71926225
Device Lot Number17CM028743
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/03/2020
Supplement Date Received by Manufacturer11/22/2020
Initial Report FDA Received Date03/30/2020
Supplement Report FDA Received Date12/01/2020
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 Hospitalization; Required Intervention;
Patient Age56 YR
Patient Weight95
-
-