MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA STAB+ INS 12.5MM SZ4; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2741
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	10/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was showing signs of draining from his wound.Patient was brought to or for left knee washout i and d poly swap.No instruments broke during case.Nothing removed from patient.Doi: (b)(6) 2019.Dor: (b)(6) 2019.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.Investigation summary: no device associated with this report was received for examination.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.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.
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 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
On (b)(6) 2019, the patient had a left total knee arthroplasty revision of tibial tray and insert to address failed left tka with medial tibial bone collapse.The postop diagnosis included bone compression and malalignment of the tibial tray.The tibial tray was also noted to be loose.The femoral component was noted to be intact and retained.Intraoperative radiographs were noted to show a non-displaced fracture of the medial tibial plateau.(b)(6) 2019 wash out ¿ positive for infection.(b)(6) 2019 the patient had an irrigation and debridement with poly exchange, septic total knee to address acutely septic revision, left total knee.Preoperative x-ray notes there is joint effusion and swelling.Doi: (b)(6) 2019.Dor: (b)(6) 2019.Left hip 2nd revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.
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: 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
The medical records the events dates of the superficial i&ds occurred on 24-oct-2019 and 12-nov-2019 which are considered continued events of the i&d and poly exchange that occurred on this pc.During this time, the patient also underwent 42 days of iv antibiotics.

• Brand Name: PFC SIGMA STAB+ INS 12.5MM SZ4
• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15208969
• Report Number: 1818910-2022-15589
• Device Sequence Number: 2123609
• Product Code: JWH
• UDI-Device Identifier: 10603295244226
• UDI-Public: 10603295244226
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K971189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2022

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: 96-2741
• Device Catalogue Number: 962741
• Device Lot Number: HZ6391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 12/21/2022; 01/16/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/14/2022; 01/09/2023; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• 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: PFC* MOD PLUS TIBIAL TRAY SZ 4; PFC*MOD PL TB WDG HEMI-20D SZ4; UNIVERSAL STEM 115X16MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male