MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Erythema (1840); Pain (1994); Discomfort (2330)
Date of Event	06/27/2022
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 vascular pe.Event is serious and is considered moderate.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2022.Date of event: (b)(6) 2022.Right knee.Treatment: injected medication (heparin drip).
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.
Event or Problem Description
On (b)(6) 2022, the patient had a (right-left) cement total knee arthroplasty to address primary osteoarthritis, end-stage.It should be noted the operative notes switch from left to right in the wording.Depuy component, including depuy patella and depuy cement were used during the procedure.(b)(6) 2022 medical records noted acute respiratory failure most likely due to pulmonary emboli found on cta on (b)(6) 2022 medical records note the patient has pain and inhibition.The patient developed a pe postoperatively.The patient reported feeling a pop inside her knee and has had significant pain and discomfort.There is some redness along the distal portion of the incision.Radiographs are reported to show an avulsion fracture off the interior pole of her patella with minimal migration.
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.

• 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): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15029236
• Report Number: 1818910-2022-13133
• Device Sequence Number: 4557407
• Product Code: JWH
• UDI-Device Identifier: 10603295231967
• UDI-Public: 10603295231967
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/15/2022

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: 96-0004
• Device Catalogue Number: 960004
• Device Lot Number: D21050682
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 08/01/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 07/20/2022; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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 1 40G.; PFC*SIGMA C/R NPOR FEM LT SZ 4.; PFC*SIGMA/OV/DOME PAT 3PEG,38.; SIG MOD TIB TRAY CEM COCR 4.; SIGMA PLI XLK INS 4 10MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Ethnicity: Hispanic
• Patient Race: White