MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 10; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Muscular Rigidity (1968); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/31/2021
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
Clinical notification received for revision of left total knee to address infection on (b)(6) 2017, the patient underwent a primary left knee arthroplasty to address osteoarthritis.Depuy products and cement were used.There were no indicated intra-operative complications.On (b)(6) 2021, the patient underwent a left knee revision to address infection, pain, swelling, erythema, and stiffness.The surgeon identified the issue as acute hematogenous sepsis.The surgeon revised the tibial insert, performed an irrigation and debridement, and placed antibiotic pellets.There were no indicated intra-operative complications.Date of implantation: (b)(6) 2017.Date of revision: (b)(6) 2021.(left knee).Treatment: washout i&d with revision of tibial insert.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records reviewed and indicated that on (b)(6) 2017, the patient underwent a primary left knee arthroplasty to address osteoarthritis.Depuy products and cement were used.There were no indicated intra-operative complications.On (b)(6) 2021, the patient underwent a left knee revision to address infection, pain, swelling, erythema, and stiffness.The surgeon identified the issue as acute hematogenous sepsis.The surgeon revised the tibial insert, performed an irrigation and debridement, and placed antibiotic pellets.There were no indicated intra-operative complications.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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 10
• 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: 12529323
• Report Number: 1818910-2021-21109
• Device Sequence Number: 4068233
• Product Code: NJL
• UDI-Device Identifier: 10603295076209
• UDI-Public: 10603295076209
• 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
• 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,Followup
• Report Date (Section B): 09/07/2021

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: 1961-92-041
• Device Catalogue Number: 196192041
• Device Lot Number: 8471525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 11/01/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/29/2021; 11/01/2021
• 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,41; SIG RP AOX CRV INS SZ4 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 129