MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled "a randomized, double-blind, placebo controlled trial on the efficacy of tranexamic acid combined with rivaroxaban thromboprophylaxis in reducing blood loss after primary cementless total hip arthroplasty" written by a.Clavé, r.Gérard, j.Lacroix, c.Baynat, m.Danguy des déserts, f.Gatineau, and d.Mottier published by the bone & joint journal in 2019 was reviewed.The study aimed to determine whether two intravenous (iv) txa regimens (a three-hour two-dose (shorttxa) and 11-hour four-dose (long-txa) were more effective than placebo in reducing perioperative real blood loss (rbl, between baseline and day 3 postoperatively) in patients undergoing tha who receive rivaroxaban as thromboprophylaxis.The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol.229 patient were implanted with a corail stem and pinnacle cup.The patient were divided into three groups- placebo (75 patients), short-txa (76 patients), and long-txa (78 patients).Adverse event involving depuy ¿ synthes products: placebo group ¿ minor bleeding (2 patients), major bleeding (9 patients), blood transfusions >2rbc units (6 patients) short-txa ¿ minor bleeding (1 patient), major bleeding (1 patient), blood transfusions >2rbc units (2 patients) long-txa ¿ minor bleeding (0 patients), major bleeding (4 patients), blood transfusions >2rbc units (3 patients), acute coronary syndrome (1 patient), bleeding leading to re-operation (2 patients).

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 HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12665713
• MDR Text Key: 277438441
• Report Number: 1818910-2021-23051
• Device Sequence Number: 1
• Product Code: JDI
• 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: 10/08/2021

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 HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1