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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,17.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,17.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 962364
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Date of Event 12/18/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(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 pain and poor motion.The surgeon removed and replaced poly insert and added a patella component.
 
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Brand Name
TC3 RP TIBIAL INSERT S5,17.5
Common Device Name
SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8244425
Report Number1818910-2019-80781
Device Sequence Number11406840
Product Code JDI
UDI-Device Identifier10603295242536
UDI-Public10603295242536
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
K802627
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/18/2018
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 Number962364
Device Lot Number204383
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/18/2018
Initial Report FDA Received Date01/14/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age79 YR
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