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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Catalog Number 74021157
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 03/18/2018
Event Type  Injury  
Event Description
It was reported that the patient was hospitalized and treated with heparin due to deep vein thrombosis.
 
Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
 
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Brand Name
KNEE IMPLANT
Type of Device
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8746919
MDR Text Key149618449
Report Number1020279-2019-02598
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
PMA/PMN Number
K121443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study,use
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number74021157
Device Lot Number17KM06713
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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