MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE TIBIAL INSERT SIGMA

Catalog Number UNK KNEE TIBIAL INSERT SIGMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Nausea (1970); Pneumonia (2011); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Thromboembolism (2654)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Literature article entitled effect of fast-track surgery in elderly patients undergoing primary total knee arthroplasty written by ma pengtao, mao yulu, zhao guangli, li ruibo, zhang yan, sun xiuyan.Published in chin j injury repair and wound healing; published online (b)(6) 2021 was reviewed.The article's purpose was to ¿investigate the application of fast-track surgery (fts) in elderly patients undergoing primary total knee arthroplasty effect.Patient data: 113 male and 115 female elderly patients which underwent single knee arthroplasty from (b)(6) 2018 to (b)(6) 2019.Depuy products: sigma posterior stabilized knee prosthesis.Cement manufacturer is unknown.Adverse events: intra-op hypothermia ¿ treated with intra-op heat preservation measures.Post-op nausea and vomiting ¿ treated with iv ondansetron.Incision infection ¿ treated with wound cleanse and dressing change.Urinary tract infection ¿ treated with urethral care and antibiotics.Lower extremity deep venous thrombosis ¿ treated with antithrombotic therapy.Post-op pneumonia ¿ treated with medication via atomization inhalation.Urinary retention or incontinence ¿ treated with catheterization.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE TIBIAL INSERT SIGMA
• Type of Device: KNEE TIBIAL INSERT
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14631422
• MDR Text Key: 293541590
• Report Number: 1818910-2022-10353
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL INSERT SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention