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

Catalog Number UNK KNEE FEMORAL SIGMA

Device Problem Off-Label Use (1494)

Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: yang l, lin z, jianping x, et al.Population with hypercoagulant condition during total knee replacement control studies with hemostatic bands.Chinese journal of joint surgery (electronic edition), august 2018, 12(4):495-500.Objective and methods: the purpose of this article was to explore the postoperative effect of different hemostatic bands on perioperative blood production in a population of 92 patients with hypercoagulation status during total knee replacement.Inclusion criteria were patients with a plasma d-dimer higher than 1000 jig/l ¿ a value that exceeded more than one time of the upper limit of the normal value.In patients with hypercoagulant status, higher d-dimer levels in plasma suggest a higher likelihood of vascular-related complications.All patients received a pfc sigma pr tka.There is insufficient information to determine the manufacturer of the cement utilized in the procedure or if the patellas were resurfaced.46 patients only had tourniquet only during the cementation process and 46 had a tourniquet applied from incision to wound closure.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: pfc sigma rp construct including femoral component, tibial insert, and tibial tray adverse event(s) and provided interventions associated with depuy devices: 22 patient received postoperative blood transfusions 7 postoperative asymptomatic dvt- 6 treated conservatively and 1 treated with embolectomy 21 intramuscular or small vein thrombi- treated with oral anticoagulants and venous pumps 1 femoral thrombosis with associated swelling.

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: 16656490
• MDR Text Key: 312438003
• Report Number: 1818910-2023-07096
• 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: 03/31/2023

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: 03/31/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/05/2023
• 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