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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 Loss of or Failure to Bond (1068)
Patient Problem 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. (b)(4).

 
Event Description

The literature article entitled, "cellular mediators secreted by interfacial membranes obtained at revision total hip arthroplasty" written by arun s. Shanbhag, phd, joshua j. Jacobs, md, jonathan black, phd, jorge o. Galante, md, and tibor t. Glant, md, phd published by the journal of arthroplasty vol. 10 no. 4 1995 was reviewed. The article's purpose to report the cytokine/cellular mediator aspect from cemented and non cemented thas. It is noted that table 1 is a table of revisions and 3 cases are identified with depuy products. Each case is captured individually in linked complaints. Only stems are identified and they are all cemented with no further information provided regarding on the adverse events. Cement manufacturer not identified and specific loosening interface is not identified. This complaint captures cemented case 1 of (b)(6) male that received revision to aml stem for aseptic loosening.

 
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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, IN 46581-0988
6103142063
MDR Report Key9417644
MDR Text Key185196879
Report Number1818910-2019-118658
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/12/2019
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
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received01/03/2020
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: 12/05/2019 Patient Sequence Number: 1
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