MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-053
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for post op mi.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 and left knee).Treatment: oral medication (plavix).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.
Event or Problem Description
On (b)(6) 2022, the patient had bilateral cemented total knee arthroplasties to address primary osteoarthritis, end-stage.Depuy components, including depuy patella and depuy cement were used during this procedure.The indications for surgery included a previous tibial plateau fracture on the left that had hardware removed a few months prior.The patient had end-stage valgus arthrosis on the left and varus arthrosis on the right with bilateral patellofemoral disease.(b)(6) 2022, medical records note that on post surgery day 2, the patient began having chest pain, with elevated troponins and eventually underwent stent placement.Patient discharged day 5 post op.(b)(6) 2022, medical records note that the patient has been having trouble with constipation, which has been chronic for the patient due to narcotic use.Otherwise, no concerns.
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.H10 additional narrative: added: b5, b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SIG RP AOX CRV INS SZ5 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16193820
• Report Number: 1818910-2023-01310
• Device Sequence Number: 17594198
• Product Code: NJL
• UDI-Device Identifier: 10603295076261
• UDI-Public: 10603295076261
• 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: 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): 01/18/2023

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: 1961-92-053
• Device Catalogue Number: 196192053
• Device Lot Number: 3909308
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 02/03/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/02/2023; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2022
• 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; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White