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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 5 20.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 5 20.0; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 96-2155
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Laxity (4526)
Date of Event 01/20/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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 due to pain and instability.No additional information was available.Doi: (b)(6) 2016 dor: (b)(6) 2021 right knee.
 
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.Should additional information be received, the information will be reviewed and the investigation may 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
PFC SIGMARP STB TB IN 5 20.0
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 Key11251842
Report Number1818910-2021-02092
Device Sequence Number11400926
Product Code NJL
UDI-Device Identifier10603295241447
UDI-Public10603295241447
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
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) 01/20/2021
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 Number96-2155
Device Catalogue Number962155
Device Lot Number8103961
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/20/2021
Supplement Date Received by Manufacturer03/05/2021
Initial Report FDA Received Date01/29/2021
Supplement Report FDA Received Date03/08/2021
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
PFC SIGMARP STB TB IN 5 20.0; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SIGMA PS CEM FEM SZ5 R; UNIVERSAL STEM 115X20MM FLUTED; PFC SIGMARP STB TB IN 5 20.0; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SIGMA PS CEM FEM SZ5 R; UNIVERSAL STEM 115X20MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
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