MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL SIGMA; FEMORAL

Catalog Number UNK KNEE FEMORAL SIGMA

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

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194); Numbness (2415); Swelling/ Edema (4577)

Event Date 02/01/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: wang, j., feng s, huang h, wang x, wang s, shao w, wang y, ma j.The hemostatic effect of tranexamic acid was compared during tka according to the route of use.Chinese journal of bone and joint injury.2020 feb;35(2):120-124.Doi: 10.7531/j.Issn.1672-9935.2020.02.003.Objective and methods the purpose of this study is to compare the hemostatic efficacy and safety of tranexamic acid (txa) administered by different routes during unilateral total knee replacement (tka) procedures performed on 108 patients with osteoarthritis between december 2016 and december 2017.The data was collected for the first 6 weeks following primary tka.All patients received txa during primary implantation of a depuy fixed-back pfc sigma cemented tka.There is insufficient information to determine if the patellas were resurfaced and the manufacturer of the cement is unknown.This complaint will only capture the results for the depuy pfc sigma devices.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy pfc sigma fb tkas consisting of a femoral component, tibial insert, and tibial tray adverse event(s) and provided interventions associated with depuy devices: 18 patients required postoperative transfusions due to blood loss.Some of these patients also experienced dizziness which resolved after the transfusion.The authors note that some patients experienced lower limb swelling, subcutaneous petechiae (captured as hemorrhage) around the incision site, and numbness in the first 7 days after the procedure that resolved without sequelae.These are expected findings immediately after major surgery and the authors specified that these were not adverse events that required medical or surgical intervention.

Manufacturer Narrative

Product complaint # : (b)(4).Udi the device catalog number is unknown; therefore, udi is unavailable.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.

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 FEMORAL SIGMA
• Type of Device: FEMORAL
• 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: 16597741
• MDR Text Key: 311921067
• Report Number: 1818910-2023-06453
• 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: 03/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 03/30/2023
• 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