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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Heart Failure (2206)
Event Date 10/19/2016
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. (b)(4).
 
Event Description
The literature article entitled, "heart failure after conventional metal-on-metal hip replacements" written by marianne h gillam, nicole l pratt, maria c s inacio, elizabeth e roughead, sepehr shakib, stephen j nicholls and stephen e graves published by acta orthopaedica issn: 1745-3674 (print) 1745-3682 (online) journal homepage: http://www. Tandfonline. Com/loi/iort20 published online 19 october 2016 was reviewed. The article's purpose was to compare the risk of heart failure in patients with conventional mom (metal on metal) total hip arthroplasty and in those with mop (metal on poly) thas. Data was compiled from thas provided january 1, 2004 and december 31, 2012 using the australian government department of veterans' affairs health claims database. Any patient who had a record for heart failure in the year prior to the tha were excluded in addition to those who were dispensed heart failure medication in the year before. Data was filtered by a unique billing code and the final study data was from 4,019 patients in which 3,546 received mop prosthesis, 121 received asr xl prostheses, 231 received lh (large head) mom prostheses, and 121 received sh (small head) mom prostheses. It is noted that the article provides a mortality rate but it is not specifically related to the implants. Results were that men who received asr xl prostheses were found to have the highest rate of hospitalization for heart failure amongst the three bearing surfaces categories, and the article notes that asr xl has the highest rate of revision. The article alleges "the idea that the association between heart failure and the use of the asr xl is real. " depuy products utilized: asr xl. Adverse events: heart failure.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9312216
MDR Text Key182250990
Report Number1818910-2019-113550
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
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