MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Cardiovascular Insufficiency (4445); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2019

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.

Event Description

Literature 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,¿ by a.Clavé, et.Al., published by the bone and joint journal (2019), vol.101-5, no.2, pp.207-2012, was reviewed.The purpose of this study was to determine whether two intravenous (iv) txa regimens (a three-hour two-dose (short-txa) 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 authors studied 218 patients who received anticoagulant therapy during implantation of a depuy corail/pinnacle thas implanted between october 2015 and may 2018 to treat rapidly destructive osteoarthritis, them measured the need for blood transfusion postoperatively.The manufacturer of the articulating surfaces was not provided but assumed to be depuy.There were no allegations of product defect within the text of this article.Adverse events: 3 cases of minor bleeding- no treatment provided.14 cases of major bleeding and reduced hct¿ treated with iron supplementation and/or prbc administration.2 cases of bleeding leading to reoperation- type of operation no specified.10 cases of decreased hg lees than or equal to 2 g/dl- treated with iron.Supplementation or prbc transfusion.2 cases of transfusion greater than or equal to 2 rbc units.1 case of acute coronary syndrome- no treatment other than transfusion is specified.Captured in this complaint: pinnacle/corail tha: anemia, cardiovascular insufficiency, hemorrhage, blood.Transfusion, additional unplanned surgery.

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.

Manufacturer Narrative

Product complaint # (b)(4).H10 additional narrative: reportability changed from malfunction to serious injury.Updated b1, b2, h1, and h6.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.B1.B2, h6, h1.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12391237
• MDR Text Key: 268967401
• Report Number: 1818910-2021-18954
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 08/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/13/2021; 11/08/2021
• Supplement Dates FDA Received: 09/13/2021; 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention