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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 TC3 RP TIBIAL INSERT S5,20.0; KNEE TIBIAL TRAY
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DEPUY IRELAND - 9616671 TC3 RP TIBIAL INSERT S5,20.0; KNEE TIBIAL TRAY Back to Search Results
Catalog Number 962365
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Patient was revised to address infection.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
TC3 RP TIBIAL INSERT S5,20.0
Common Device Name
KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork IN
EI 
MDR Report Key7071708
Report Number1818910-2017-50448
Device Sequence Number11042482
Product Code NJL
UDI-Device Identifier10603295242543
UDI-Public10603295242543
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 11/01/2017
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 Date09/30/2021
Device Catalogue Number962365
Device Lot NumberC91547
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/01/2017
Supplement Date Received by Manufacturer05/08/2018
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date05/09/2018
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;
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