MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Fall (1848); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	07/08/2020
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 notification received for revision of right total knee to address infection.Date of implantation: (b)(6) 2009, date of revision #1: (b)(6) 2020 (insert revised), date of revision #2: (b)(6) 2020, (right knee).Treatment: explantation of femur, tibial tray, tibial insert, and patella products/placement of antibiotic spacer.
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: SIG RP AOX CRV INS SZ4 17.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10547515
• Report Number: 1818910-2020-20358
• Device Sequence Number: 11599187
• Product Code: NJL
• UDI-Device Identifier: 10603295076230
• UDI-Public: 10603295076230
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 1961-92-044
• Device Catalogue Number: 196192044
• Device Lot Number: 8978018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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*SIGMA C/R NPOR FEM RT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM RT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 215