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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 Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); 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. 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. (b)(4).
 
Event Description
"literature article abstract entitled, ¿large-diameter metal-on-metal total hip arthroplasty: 5 years of follow-up¿ by vittorio calvisi, published in hip international (2015), ¿poster sessions¿, vol. 25, suppl. 1, entry p97, page s-99, was reviewed. The purpose of the article is to review the long-term outcomes of the asr-xl mom tha. Implanted depuy products: asr-xl tha including the cup, femoral head, and femoral segment. The stem used was not known but assumed to be a depuy product. Results: there were 41 revisions performed. The abstract did not provide information regarding the condition of the explanted products. All revisions had intraoperative confirmation if periarticular joint fluid consistent with foreign body reaction. All patients had elevated blood metal ions greater than 7 ppb. 10 cup revisions due to migration of the cup. 1 complete revision for pain and severe mobility decrease secondary to foreign body reaction and elevated blood metal ions. 30 complete revisions due to elevated blood metal ions and foreign body reaction. Captured in this complaint: asr-xl cup, head, and augment: no reported product problem. Unknown femoral stem: no reported product problem. Patient harms: pain, medical device site joint range of motion decreased, elevated blood metal ions, foreign body reaction, surgical intervention, and medical device removal. There was insufficient information provided to determine of there was bearing wear on the articulating surfaces. ".
 
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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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9417941
MDR Text Key185224021
Report Number1818910-2019-120940
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
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
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
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 Received11/14/2019
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: 12/05/2019 Patient Sequence Number: 1
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