MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-50-400
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.Follow-up is being conducted to obtain the legal contact information.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
Medical records and x-ray films received on (b)(6) 2019.Doi: (b)(6) 2016, dor: unknown, right knee.
Event or Problem Description
Added patient code allergic reaction (due to a confirmed nickel allergy on (b)(6) 2020) and musculoskeletal stiffness (based on the adverse events on (b)(6) 2018).
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.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.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.

• Brand Name: SIGMA PS CEM FEM SZ4 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: 10715467
• Report Number: 1818910-2020-23002
• Device Sequence Number: 19794627
• Product Code: JWH
• UDI-Device Identifier: 10603295075141
• UDI-Public: 10603295075141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2020

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 Expiration Date: 09/30/2025
• Device Model Number: 1960-50-400
• Device Catalogue Number: 196050400
• Device Lot Number: 8187280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 11/30/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/06/2020; 12/01/2020
• 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: MBT CEM KEEL TIB TRAY SZ4; PFC SIGMARP STB TB IN 4 10.0; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA PS CEM FEM SZ4 R; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR