MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2021
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
On (b)(6) 2015, the patient had a bilateral cemented total knee arthroplasty to address bilateral osteoarthritis.Depuy components, including depuy patella were used during the procedure.On (b)(6) 2017, the patient had a revision left total knee arthroplasty to address acute hematogenous sepsis.The right knee was also aspirated.Prior to surgery, the patient was noted to have pain.The patient was noted to have had a prior aspiration and was positive for infection.On (b)(6) 2021, the patient had a revision of all components, left total knee arthroplasty, to address chronic infection.The tibial insert was revised.Prior to surgery the patient was noted to have pain, swelling, discomfort, effusion, and recurrent infection.The patient is having a stage 1 revision for infection now.All components were noted to be well fixed prior to removal.Depuy components were used during this procedure.Date of implantation: (b)(6) 2015.Date of revision #1: (b)(6) 2017 (insert).Date of event (onset): (b)(6) 2021.(left knee).
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 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.

• Brand Name: SIG RP AOX CRV INS SZ4 15
• 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: 11871338
• Report Number: 1818910-2021-11007
• Device Sequence Number: 10974672
• Product Code: NJL
• UDI-Device Identifier: 10603295076223
• UDI-Public: 10603295076223
• 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: 2017
• 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): 04/28/2021

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: 1961-92-043
• Device Catalogue Number: 196192043
• Device Lot Number: 7999774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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 SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 15; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 116