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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY

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SMITH & NEPHEW, INC. JOURNEY TIBIAL IMPL IMPACTOR PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY Back to Search Results
Model Number 74018901
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 08/17/2020
Event Type  Malfunction  
Event Description

It was reported that the inner plastic of the journey tibial impl impactor has been found chipped. No case involved.

 
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Brand NameJOURNEY TIBIAL IMPL IMPACTOR
Type of DevicePROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks road
memphis, TN 38116
7273993737
MDR Report Key10523552
MDR Text Key206713713
Report Number1020279-2020-04557
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 09/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number74018901
Device Catalogue Number74018901
Device LOT Number17JSM0475
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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