MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL

Catalog Number UNK KNEE FEMORAL

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)

Event Date 06/17/2009

Event Type  Injury  

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.(b)(4).

Event Description

Literature article entitled, ¿simultaneous bilateral versus unilateral computer-assisted total knee arthroplasty: a prospective comparison of early postoperative pain and functional recovery¿ by gautam m.Shetty, et al, published by the knee (2010), vol.17, pp.191-195, was reviewed.The purpose of this article was to determine if computer-assisted simultaneous bilateral tkas (sbtkas) are more painful and the postoperative functional recovery slower compared to unilateral tkas implanted in 100 patients between july 2008 and december 2008.All patients received primary pfc sigma tkas with patellar resurfacing.The cement manufacturer is unknown.Implanted depuy products: primary pfc sigma total knee with patellar resurfacing.The surgeons used fixed bearings, mobile bearings, or all-polyethylene tibias depending on patient requirements but did not provide information to determine the quantity or results of each option.Bilateral tka results: 9 patient received transfusions of packed red blood cells to treat intraoperative blood loss.2 cases of hyponatremia requiring medical intervention.2 cases of postoperative urinary retention requiring insertion of a foley catheter.1 case of postoperative rectal bleeding due to intraoperative administration of heparin.Bleeding resolved with discontinuation of heparin.Unilateral tka results: 1 patient required admission to the icu to treat postoperative angina 1 instance of postoperative dyspnea treated with administration of inhalant medication.1 instance of hyponatremia treated with medical intervention.1 instance of urinary retention treated with foley catheterization.Captured in this complaint: there were no reported product problems or revisions of the patella, femoral component, tibial insert, or tibial tray in either study group.Patient harms for the bilateral group: serious injury, major bleed, urinary retention, blood transfusion.Patient harms for unilateral group captured on linked pc: serious injury, chest pain, dyspnea, major bleed, blood transfusion, urinary retention.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9973756
• MDR Text Key: 188367033
• Report Number: 1818910-2020-10955
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention