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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,15.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,15.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT Back to Search Results
Model Number 96-2353
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 08/04/2021
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
The patient was revised due to infection.Poly exchange was performed.Doi: (b)(6) 2021, dor: (b)(6) 2021, left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
TC3 RP TIBIAL INSERT S4,15.0
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 Key12360042
Report Number1818910-2021-18505
Device Sequence Number17127752
Product Code NJL
UDI-Device Identifier10603295242376
UDI-Public10603295242376
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/04/2021
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 Model Number96-2353
Device Catalogue Number962353
Device Lot NumberHX9313
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/04/2021
Supplement Date Received by Manufacturer09/02/2021
Initial Report FDA Received Date08/24/2021
Supplement Report FDA Received Date09/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
TC3 RP TIBIAL INSERT S4,15.0.; UNKNOWN KNEE FEMORAL.; UNKNOWN KNEE PATELLA.; UNKNOWN KNEE TIBIAL TRAY.; TC3 RP TIBIAL INSERT S4,15.0; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL TRAY
Outcome Attributed to Adverse Event Required Intervention;
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