MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,22.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2356
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/26/2020
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 of right total knee to address infection -- hematogenous seeding, (b)(6), being treated with doxycycline.Date of implantation: (b)(6) 2014, date of revision: (b)(6) 2020, (right knee).Treatment: i&d with revision of tibial insert.
Event or Problem Description
Medical records received.On (b)(6) 2020, the patient underwent a right knee revision with tibial insert exchange, irrigation and debridement, and placement of antibiotic pellet to address infection.The patient was experiencing pain, swelling, warmth, and instability.The surgeon noted synovitis within the operative note.The tibial tray, patellar component, and femoral component were retained.There were no indicated intra-operative complications.
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: b5, h6 health effect - clinical code.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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TC3 RP TIBIAL INSERT S4,22.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11404699
• Report Number: 1818910-2021-04217
• Device Sequence Number: 11904121
• Product Code: NJL
• UDI-Device Identifier: 10603295242437
• UDI-Public: 10603295242437
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2021

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: 96-2356
• Device Catalogue Number: 962356
• Device Lot Number: 243750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 04/19/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/13/2021; 04/20/2021
• 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 2 20G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,22.5; UNIVERSAL FEM SLV DIS POR 40MM; DEPUY CMW 2 20G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 8MM; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA DIS AUG 4MM,SZ4,RGHT; PFC*SIGMA TC3 FEM RT SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,22.5; UNIVERSAL FEM SLV DIS POR 40MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 100