MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Fluid Discharge (2686)
Date of Event	06/09/2021
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
Clinical adverse event received for expracapsular drainage.Event is not serious and is considered mild.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021, (left knee).Treatment: placement in knee immobilizer and recheck wound in two days.On (b)(6) 2021 the patient had a left hybrid total knee arthroplasty to address primary osteoarthritis, end-stage.Depuy components, including depuy patella, along with depuy cement were used during this procedure.On (b)(6) 2021 patient was admitted to hospital for sepsis, which the surgeon noted that ¿they think is coming from her gallbladder¿.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 C/R POROCOAT FEM LT SZ 4N
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12200580
• Report Number: 1818910-2021-15565
• Device Sequence Number: 4255331
• Product Code: MBH
• UDI-Device Identifier: 10603295223450
• UDI-Public: 10603295223450
• 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
• 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): 06/09/2021

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: 94-0019
• Device Catalogue Number: 940019
• Device Lot Number: H65393
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM LT SZ 4N; SIG RP AOX CRV INS SZ4 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 109