MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440)
Date of Event	01/07/2021
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
Clinical adverse event received for dvt and hemarthrosis that resulted from blood thinning medication to treat dvt.Event is serious and is considered moderate.Event is definitely not related to device and possibly related to procedure.Date of implant: (b)(6) 2020, date of event: (b)(6) 2021, (right knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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.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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11223601
• Report Number: 1818910-2021-01766
• Device Sequence Number: 19772160
• Product Code: JWH
• UDI-Device Identifier: 10603295232032
• UDI-Public: 10603295232032
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2021

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 Number: 96-0014
• Device Catalogue Number: 960014
• Device Lot Number: D17081668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/25/2021; 03/08/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/03/2021; 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 1 40G; PFC*SIGMA C/R NPOR FEM RT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIGMA PLI XLK INS 4 12.5MM; DEPUY CMW 1 40G; PFC*SIGMA C/R NPOR FEM RT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIGMA PLI XLK INS 4 12.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 84