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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Test Result (2695); No Code Available (3191)
Event Date 04/16/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number. The correction/removal reporting number listed applies to the corresponding product code sold domestically. (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, "ultrasound-based decision making following metal-on-metal hip arthroplasty" written by remo goderecci, andrea fidanza, stefano necozione, vincenzo francione, pier francesco indelli, and vittorio calvisi published by journal of clinical orthopaedics and trauma made available online 16 april 2019 was reviewed. The article's purpose is to determine the association between metal ions blood levels and the amount and quality of the periprosthetic fluid collection detected during ultrasound investigation. Data was compiled from 116 patients (56 males and 60 females) with age range of 15-86 years. All patients received depuy asr xl mom thas (123 total thas) between 2006 and 2009. The article does not identify the femoral stems utilized with the asr xl construct. Fifty patients (51 implants) underwent revision with range of 1. 79-9. 26 years from primary implantation. The article relates any findings of armd (adverse reaction to metal debris), altr (adverse local tissue reactions), and alval (aseptic lymphocyte-dominated vasculitis-associated lesions) to the release of co (cobalt) and cr (chromium) from the metal-on-metal bearing surface. The use of the ultrasound was to detect clinically significant altrs. Co and cr blood tests were performed by the laboratory of clinical chemistry at charing cross hospital (london, england), and the results were categorized according to the italian society for orthopaedics and traumatology's guidelines. This complaint captures the associated adverse events. Depuy products: asr xl cup, asr xl femoral head, asr xl femoral sleeve (augment). Reasons for revision: elevated ion levels. Pseudotumor. Altr.
 
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Brand NameUNKNOWN HIP FEMORAL AUGMENT
Type of DeviceHIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10291614
MDR Text Key200443576
Report Number1818910-2020-16196
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
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 Received07/27/2020
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
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 07/17/2020 Patient Sequence Number: 1
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