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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  TC3 RP TIBIAL INSERT S5,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS, INC. 1818910  TC3 RP TIBIAL INSERT S5,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 962362
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/07/2018
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
Revised to address pain.
 
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
 
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Brand Name
TC3 RP TIBIAL INSERT S5,12.5
Common Device Name
SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8133645
Report Number1818910-2018-77259
Device Sequence Number16178294
Product Code NJL
UDI-Device Identifier10603295242499
UDI-Public10603295242499
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P830055
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) 11/07/2018
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 Number962362
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/07/2018
Supplement Date Received by Manufacturer12/10/2018
Initial Report FDA Received Date12/05/2018
Supplement Report FDA Received Date12/10/2018
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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