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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 96-2042
Medical Device Problem Codes Device Markings/Labelling Problem (2911); Illegible Information (4050)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/06/2020
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
The patient was revised to address loosening of the tibial component at the cement to implant interface.Unknown cement was used.The tibial tray and poly were replaced.The lot number on the poly was damaged and only part of the number was legible.Doi: (b)(6) 2007, dor: (b)(6) 2020, left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.
 
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Brand Name
PFC SIGMARP CV TB/IN S4 12.5
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 Key10303540
Report Number1818910-2020-16442
Device Sequence Number19502840
Product Code NJL
UDI-Device Identifier10603295240822
UDI-Public10603295240822
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/06/2020
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? Yes
Operator of Device Health Professional
Device Model Number96-2042
Device Catalogue Number962042
Device Lot Number2230836
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/06/2020
Supplement Date Received by Manufacturer08/24/2020
Initial Report FDA Received Date07/21/2020
Supplement Report FDA Received Date08/25/2020
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
MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP CV TB/IN S4 12.5; MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP CV TB/IN S4 12.5
Outcome Attributed to Adverse Event Required Intervention;
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