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

Model Number	94-0023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Swelling/ Edema (4577)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study: (b)(6).Clinical adverse event received for blood in joint; snynovial pinching probable event is not serious and is considered mild.Event is possibly related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2009.Date of event (onset): (b)(6) 2021.(right knee) treatment: right knee aspirated - blood tinged aspirate/ medrol dosepak given /if no improvement, may need an exploration of the knee with poly exchange.
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.
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.The provided evidence shows a total left and right knee arthroplasties with no signs of bone or assembling abnormality; according to the visual information, there is no evidence that shows the blood in joint and synovial pinching alleged were consequence of a device defect or failure.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.
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
Primary operative notes on (b)(6) 2009, indicate the patient received a right total knee replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Office notes on (b)(6) 2021, indicate the patient is experiencing pain and swelling of the right knee in addition to the previously noted ae.No additional treatment provided.

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12908031
• Report Number: 1818910-2021-26610
• Device Sequence Number: 3992661
• Product Code: MBH
• UDI-Device Identifier: 10603295223474
• UDI-Public: 10603295223474
• 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: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2021

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: 94-0023
• Device Catalogue Number: 940023
• Device Lot Number: D2CJ41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/18/2021; 12/17/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/09/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2009
• 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: MBT POR KEEL TIB TRAY SZ3.; PFC SIGMARP CV TB/IN S3 10.0.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIG C/R POROCOAT FEM RT SZ 3.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 100 KG