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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ3 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ3 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1961-92-033
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abscess (1690); Unspecified Infection (1930); No Code Available (3191)
Date of Event 05/25/2017
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
Clinical notification received for revision of right total knee to address deep infection (right knee).
 
Additional Manufacturer Narrative
Product complaint # (b)(4).
 
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Brand Name
SIG RP AOX CRV INS SZ3 15
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9608217
Report Number1818910-2020-02343
Device Sequence Number14120542
Product Code NJL
UDI-Device Identifier10603295076186
UDI-Public10603295076186
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Model Number1961-92-033
Device Catalogue Number196192033
Device Lot Number8451157
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/07/2020
Supplement Date Received by Manufacturer02/03/2020
Initial Report FDA Received Date01/20/2020
Supplement Report FDA Received Date02/11/2020
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;
Patient Age67 YR
Patient Weight84
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