MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ6 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/15/2020
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 due to infection.Date of implant: (b)(6) 2011, date of revision: (b)(6) 2020, (right knee).Treatment: revision of total knee construct.

• Brand Name: SIGMA PS CEM FEM SZ6 R
• 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: 11311606
• Report Number: 1818910-2021-02801
• Device Sequence Number: 1167558
• Product Code: NJL
• UDI-Device Identifier: 10603295075172
• UDI-Public: 10603295075172
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted 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
• Report Date (Section B): 02/01/2021

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: 1960-50-600
• Device Catalogue Number: 196050600
• Device Lot Number: E3YNG4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/31/2021
• 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: PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 5; SIGMA PS CEM FEM SZ6 R; SIGMA STAB GVF INS 5 8MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 93