MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG CR NPOR FEM RT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-01-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191)
Date of Event	05/07/2020
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
On (b)(6) 2019 the patient underwent a right cemented total knee arthroplasty to address osteoarthritis, end-stage, right knee, pain, and morbid obesity.Depuy components and cement x1 were utilized and there were no complications noted.The patella was resurfaced.On (b)(6) 2020 the patient underwent a revision right total knee arthroplasty, septic arthrosis, acute, secondary to hematogenous seeding from urinary infection.It was noted that prior to the revision the patient experienced pain, discomfort, and dysfunction.The tibial insert was revised.During the procedure it was noted that the components were well fixed, but the knee contained gross pus.This is captured in (b)(4).On (b)(6) 2020 the patient was receiving intravenous antibiotics status post i&d.Medical records from (b)(6) 2019 note that six weeks post right total knee arthroplasty with wound healing issue.It had delayed healing with draining.Doe: (b)(6) 2020.Right 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.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: PFC SIG CR NPOR FEM RT SZ 4N
• 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: 10102729
• Report Number: 1818910-2020-12854
• Device Sequence Number: 3082464
• Product Code: JWH
• UDI-Device Identifier: 10603295074779
• UDI-Public: 10603295074779
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1960-01-400
• Device Catalogue Number: 196001400
• Device Lot Number: J41N37
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/01/2020
• 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: DEPUY CMW 1 40G; DEPUY CMW 1 40G; PFC SIG CR NPOR FEM RT SZ 4N; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 4; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 108