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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT11; PRSTHSS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTL/PLYMR
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SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT11; PRSTHSS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTL/PLYMR Back to Search Results
Catalog Number 74023253
Medical Device Problem Codes Break (1069); Fracture (1260)
Health Effect - Clinical Codes Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event 07/03/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to instability.At time of revision surgery it was discovered the bcs insert post had broken.
 
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.
 
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Brand Name
JOURN ART INS BCS STD 5-6 RT11
Common Device Name
PRSTHSS,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/MTL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7717796
Report Number1020279-2018-01400
Device Sequence Number995749
Product Code JWH
UDI-Device Identifier03596010555151
UDI-Public03596010555151
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/24/2018
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 Catalogue Number74023253
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/03/2018
Supplement Date Received by Manufacturer07/03/2018
Initial Report FDA Received Date07/25/2018
Supplement Report FDA Received Date09/13/2018
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 Other; Required Intervention;
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