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U.S. Department of Health and Human Services

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

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DEPUY IRELAND - 9616671 DM ACETABULARCUP54MM/44MMHEAD HIP ACETABULAR LINERS Back to Search Results
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).
 
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Brand NameDM ACETABULARCUP54MM/44MMHEAD
Type of DeviceHIP 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 Key8824348
MDR Text Key152161037
Report Number1818910-2019-99187
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
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 Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number168114F
Device Lot Number8202414
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 Received09/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2015
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
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