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

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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary:no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9312216
• MDR Text Key: 182250990
• Report Number: 1818910-2019-113550
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention