MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 01/01/2019

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

The literature article entitled, "tranexamic acid may benefit patients undergoing total hip/knee arthroplasty because of hemophilia" written by ze yu huang, qiang huang and han jiang zeng (article notes equal contribution by authors) published by bmc musculoskeletal disorders 2019 was reviewed.The article's purpose "to address the following study questions: (1) how much can txa usage minimize the perioperative blood loss and related parameters, such as transfusion rate associated with the patients treated with tja for hemophilia; (2) are there any other benefits hemophiliacs can gain from txa usage? (3) is it safe to use txa in hemophiliacs?" data was compiled from two groups and including two different procedures: tranexamic acid (txa) group consisting of total hip arthroplasty (tha) and total knee arthroplasty (tka); non txa group consisting of thas and tkas.Also noted that both group had number of bilateral joint implantation in thas and tkas.Cement manufacturer is not identified for tka.Implantations were performed january 2008 to august 2017.It is noted that blood transfusions were performed in each study group for both thas and tkas but the exact quantity of patients or the specifics of the procedure was not clarified for these patients.Therefore, two individual impacted products will be captured for each product platform within each product platform to represent bilateral procedures to encompass all possibilities.All implants were depuy.Figures 2-5 provide radiographic images for illustrative purposes.Depuy products: pinnacle cup, corail stem, liner (assumed), head (assumed, pfc sigma knee system (femoral, insert, tibial tray) adverse event: 1) blood loss requiring administration of blood transfusion.

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.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.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10005810
• MDR Text Key: 189583367
• Report Number: 1818910-2020-11427
• Device Sequence Number: 1
• Product Code: KWY
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention