MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-054
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 notification received for revision of right total knee to address infection.Date of implantation: (b)(6) 2019; date of revision: (b)(6) 2020; (right knee).
Additional Manufacturer Narrative
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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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
Update: medical records received on ad 13 mar 2020 patient received a depuy pfc sigma rp total knee to treat end-stage valgus osteoarthritis of the right knee.The patella was resurfaced and depuy cement was utilized.Intraoperatively, the surgeon repaired a natural tibial defect with 2 unknown fully threaded screws and cement.The procedure was completed without complications.Patient presented to the emergency room on (b)(6) 2020 with pain, swelling, and stiffness secondary to superficial wound infection.The patient was treated with iv antibiotics.Right knee x-rays identified subcutaneous emphysema.The patient did not follow postoperative treatment and antibiotic treatment protocol and the infection became deep, requiring surgical intervention.Dor: (b)(6) 2020: patient revised to treat deep infection.Upon entering the knee, the surgeon encountered and evacuated pus.A complete synovectomy was performed, and scar tissue was debrided.There were no reported product problems with the revised insert or the retained patella, femoral component, or tibial tray.The patient was revised with a depuy insert and the surgery was completed without complications.The patient was instructed to abstain from baths and to adhere to antibiotic treatment therapy.

• Brand Name: SIG RP AOX CRV INS SZ5 17.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9848813
• Report Number: 1818910-2020-08470
• Device Sequence Number: 2871568
• Product Code: JWH
• UDI-Device Identifier: 10603295076278
• UDI-Public: 10603295076278
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2020

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: 1961-92-054
• Device Catalogue Number: 196192054
• Device Lot Number: 9051503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/13/2020; 04/20/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/30/2020; 04/21/2020
• 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 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM RT SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 82