MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DM ACETABULARCUP54MM/44MMHEAD HIP ACETABULAR LINERS

Catalog Number 168114F

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)

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

Patient communication received. It was reported that the patient had a hip surgery in 2016 and endoprosthesis was used. After 3 years of pain,the doctor decided to make this operation again. During the operation tissue inflammation was found because the metal penetrated into them. Also, the doctors decided to change this endoprosthesis for new and different brand. Since may 2019 the patient still cure inflammation. Doi: 2016 - dor: unknown (unk hip).

• Brand Name: DM ACETABULARCUP54MM/44MMHEAD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8824348
• MDR Text Key: 152161037
• Report Number: 1818910-2019-99187
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 168114F
• Device Lot Number: 8202414
• 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: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/24/2019 Patient Sequence Number: 1