MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	940023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Discomfort (2330); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	01/01/2024
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: dots.Clinical notification received for revision due to infection.Date of implant: (b)(6) 2021; date of revision: unk; (right knee).Treatment: revision; femoral, tibial, insert and patella were revised.
Additional Manufacturer Narrative
Product complaint (b)(4) investigation summary no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 940023>/lot h65387 combination.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 940023 /lot h65387 combination.H10 additional narrative: added: b5, d10 and h6 h6 clinical symptoms code: unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.
Event or Problem Description
Medical records received.On (b)(6) 2022: patient received a right knee i&d and primary poly swap to treat hematogenous sepsis.The patient was revised with an unknown insert.This event was noted as part of the patient¿s medical history.This is a previously unknown complaint and there are no medical records available for this event.On (b)(6) 2023: a 63-year-old female patient received a right knee stage one revision to treat pain, swelling, and discomfort secondary to acute sepsis/gross infection.The surgeon specifically notes this infection was not recurrent.Upon entering the joint, gross puss was evacuated and two capsular tears were identified.Extensor mechanism allograft was completely avascular.A scar tissue debridement was performed.There was mild-to-moderate bone loss of the tibial and femur.All components were revised and the extensor mechanism allograft from the previous repair was debrided.A competitor spacer was inserted, and the capsular tears were repaired.The procedure was completed without complications.Doi: on (b)(6) 2021, doe: on (b)(6) 2022 patella fracture repair (b)(4), ,doe: on (b)(6) 2022: cerclage removal, i&d, and extensor mechanism repair (b)(4), doe: on (b)(6) 2022: wound vac placement (b)(4), dor: on (b)(6) 2022: poly swap for sepsis (new event) dor: on (b)(6) 2023: stage 1 revision for acute sepsis (b)(4), right knee.Synopsis of medical records associated with this patient: (b)(4) : continued wound drainage.Treatment: wound vac placement.Date of implant: on (b)(6) 2021; date of event: 27/apr/2022.On (b)(6) 2022, the patient had an excision of sinus tract with debridement and suture repair to address draining sinus tract, right total knee arthroplasty wound.The indication for surgery included that the patient had a previous extensor mechanism allograft 8 weeks previously.Four weeks ago, the patient¿s cerclage wire broke there was a small draining area of the patient¿s wound.No components were removed in this procedure.Wound vac placement on (b)(6) 2022 patient reports having some drainage from her incision.It was noted there was a previous wound debridement ( on (b)(6) 2022).(b)(4): broken wire and this is increasingly causing pain.Treatment: wire removal.Date of implant: on (b)(6) 2021; date of event: 03/02/2022.(b)(4) : bone fracture of inferior pole of patella, small in nature, non-displaced.Treatment: patellar tendon repair.Date of implantation: on (b)(6) 2021; dot: on (b)(6) 2021.Office notes on (b)(6) 2021 and (b)(6) 2021 indicate the patient is experiencing pain, swelling and possible it band syndrome of the right knee.(b)(4) : revision due to acute sepsis.Treatment: revision; femoral, tibial, unknown insert, cement, and patella were revised.Date of implant: on (b)(6) 2021; dor: unk pc: on (b)(6) 2022: patient received a right knee i&d and primary poly swap to treat hematogenous sepsis.The patient was revised with an unknown insert.This event was noted as part of the patient¿s medical history.This is a previously unknown complaint and there are no medical records available for this event.
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
Operative note ad 18 oct 2024 was reviewed by clinician.On (b)(6) 2024, the patient had a right total knee revision/reimplantation of knee arthroplasty.A zimmer biomet finn hinged knee was utilized.Patient had their previous total knee explanted three months prior due to chronic sepsis.*no more specific details on previous implants provided in the new medical records.

• Brand Name: SIG C/R POROCOAT FEM RT SZ 3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• 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: 18941425
• Report Number: 1818910-2024-06164
• Device Sequence Number: 2894209
• Product Code: MBH
• UDI-Device Identifier: 10603295223474
• UDI-Public: (01)10603295223474(17)270331(10)H65387
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K062654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/20/2024

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: 940023
• Device Lot Number: H65387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 04/12/2024; 10/23/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/03/2024; 04/22/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ3 10SIG RP AOX CRV INS SZ3 10; UNKNOWN KNEE TIBIAL INSERT; ZIMMER BIOMET FINN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White