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

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problems Thrombosis/Thrombus (4440); Physical Asymmetry (4573)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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, ¿long-term outcomes of total hip arthroplasty with transverse subtrochanteric shortening osteotomy and modular stem in crowe iv developmental dysplasia. ¿, published by the journal of arthroplasty, was reviewed. The purpose of this study is to evaluate the rate of union, the revision rate, functional scores, and complications in patients with crowe iv ddh treated with total hip arthroplasty, transverse subtrochanteric shortening osteotomy, and modular stem in an average 10-year follow-up. Twenty-eight patients (33 hips) with crowe iv ddh who were operated on between 2008 and 2013 were followed. All patients underwent uncemented total hip arthroplasty with transverse subtrochanteric shortening osteotomy and anatomical acetabular cup implantation. The mean age was 36. 6 years, and the mean follow-up period was 121 months. Crowe iv ddh patients treated with transverse subtrochanteric shortening osteotomy, modular stem, and anatomic acetabular component insertion can have satisfactory and reliable 10-year clinical outcomes. Complication: 3 cases of postoperative dislocation, 2 cases of intraoperative fracture occurred during bone prep, one of the fractures had patient identifier of (b)(6) year-old female 1 case of posterior tibial venous thrombosis. Leg asymmetry was noted prior to implanting and also present in patient's post surgery.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11106891
• MDR Text Key: 233126313
• Report Number: 1818910-2021-28099
• Device Sequence Number: 1
• Product Code: KWA
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/04/2021 Patient Sequence Number: 1