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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 Date 10/12/2009
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. 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 entitled, ¿individual susceptibility to periprosthetic osteolysis is associated with altered patterns of innate immune gene expression in response to pro-inflammatory stimuli¿ by andrew gordon, et al, published by journal of orthopaedic research (2010), pp. 1127-1135, doi 10. 1002/jor. 21135, was reviewed. The purpose of this study was to examine whether individuals with a susceptibility to osteolysis after tha have quantitatively different innate immune responses to pro-inflammatory stimuli versus individuals who do not display this susceptibility. All patients in the study group were revised for osteolysis and implant loosening between march and november 2005. Implanted depuy products: charnley tha cemented with competitor cement- polyethylene head, 22-mm femoral head, and femoral stem. Results: there were no revisions or complications of the revised prostheses. This complaint captures the charnley tha index prostheses revised due to aseptic loosening secondary to osteolysis. 28 charnley cups- examination of the explanted cups identified polyethylene wear. 29 charnley stems captured in this complaint: charnley cup: implant loosening of an unknown interface, implant bearing wear. Femoral head: no reported product problem. Charnley stem: implant loosening of an unknown interface. Patient harms: osteolysis, surgical intervention, medical device removal.

 
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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
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9417829
MDR Text Key185198890
Report Number1818910-2019-120912
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
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
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 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

Patient TREATMENT DATA
Date Received: 12/05/2019 Patient Sequence Number: 1
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