MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIG RP AOX CRV INS SZ5 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-053
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2021
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
Subject id: (b)(6).Study: dots.Clinical notification received for revision due to infection.Date of implant: (b)(6) 2018, date of revision: (b)(6) 2021, (left knee).Treatment: revision of the tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available x-rays and photographs were reviewed, and the complaint cannot be confirmed.Depuy synthes considers the investigation closed at this time.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.Corrected: h6 clinical code appropriate term / code not available (e2402) to capture infection (e19) is being replaced with unspecified infection (e1906).

• Brand Name: SIG RP AOX CRV INS SZ5 15
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12533595
• Report Number: 1818910-2021-21198
• Device Sequence Number: 1414840
• Product Code: NJL
• UDI-Device Identifier: 10603295076261
• UDI-Public: 10603295076261
• 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: 2018
• Device Explanted Year: 2021
• 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): 09/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1961-92-053
• Device Catalogue Number: 196192053
• Device Lot Number: 8160263
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ5; PFC SIGMA C/R NPOR FEM LT SZ5; PFC SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 15; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ5; PFC SIGMA C/R NPOR FEM LT SZ5; PFC SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 107