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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Naturally Worn (2988)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Test Result (2695); No Code Available (3191)
Event Date 01/01/2019
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, "the 10-year outcomes of the asr xl acetabular system: a single-center experience from china" written by guojun jin, jisheng ran, weiping chen, yan xiong, jiapeng bao, and lidong wu published by journal of orthopaedic surgery and research 2019 was reviewed. The article's purpose is to assess the depuy asr xl implant design's performance with respect to: demographic characteristics of patients who underwent mom tha, the relationship between blood metal ion levels and rate of early clinical failure, the cumulative survival probability at the final follow-up, and risk factors of the revision surgery. Data was compiled from 74 prostheses followed during july 2006 to january 2010 consisting of 36 males and 38 females with age mean of 56. 12 plus/minus 13. 15 years. Femoral stems are not identified within the article. The article associates cystic changes, pseudotumor formation, metal staining in soft tissues related to component orientation and bearing surface wear as well as blood metal ion concentration. Figure 4 provides radiographic and ct scan of a revised asr xl mom prostheses with caption description indicating cystic changes in periprosthetic bone. Depuy products: asr xl cup, asr xl femoral head, asr xl sleeve (augment). Adverse events treated by revision: table 2 indicates mispositioned cups. Cystic changes (bone related). Pseudotumor formation. Metal staining in gross soft tissues. Loose cup. Acetabular stress shielding. Elevated ion levels.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10274413
MDR Text Key204176340
Report Number1818910-2020-15863
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received08/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/15/2020 Patient Sequence Number: 1
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