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

Catalog Number	196192043
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	01/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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
Study no: (b)(6).Clinical notification received for revision due to infection.Date of implant: (b)(6) 2013 date of revision: (b)(6) 2024 (left knee) treatment: insert was revised - were depuy components removed: yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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
On (b)(6) 2024, left knee was revised to address acute postoperative sepsis (infection).This is after the patient had already been treated with an external fixator for a high energy proximal tibia fracture, followed by revision of the tibial tray and insert with attune revision crs knee implants, and orif placement of two small fragment plates and screws (manufacturer not provided).Those events occurred approximately 4 weeks prior to the current event.The patient now presented with acute sepsis of the knee joint, with pain, discomfort, significant stiffness, erythema, wound drainage and swelling, surgically, the patient's left knee was irrigated and debrided with synovectomy.All implants appeared to be doing well with regard to ingrowth and fixation.The insert was revised to a 20mm thick attune crs polyethylene insert.Stimulan pellets were placed, and the wound closed.There were no complications.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18579782
• Report Number: 1818910-2024-01749
• Device Sequence Number: 8517626
• 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: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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 Catalogue Number: 196192043
• Device Lot Number: 196192043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/29/2024; 02/08/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/06/2024; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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 SIG CR NPOR FEM LT SZ 4N; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White