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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 Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2015
Event Type  Malfunction  
Manufacturer Narrative

Product complaint #: (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. - attachment: [(b)(4) literature article. Pdf, (b)(4) guidance(hip). Xlsx].

 
Event Description

"literature article entitled, ¿compared fixation and survival of 280 lateralised vs 527 standard cementless stems after two years (1¿7)¿ by o. Cantin, et al, published by orthopaedics and traumatology: surgery and research (2015), vol. 101, pp. 775-780, was reviewed. The objectives of this study were to compare cementless lateralized stems and standard stems of identical design in terms of radiological bony on growth and survival. This article does not identify the cups, heads, or acetabular liners used with the corail stems. Implanted depuy products: cementless corail standard kla and cementless corail lateralized kho stems. The results for the kho lateralized have been previously reported in (b)(4) and will therefore not be captured in this complaint. This complaint will capture the results associated with the corail standard kla stem. Results: there were no revisions or interventions reported for the standard kla stem. There were an unknown number of radiographically identified mispositioned stems. There were incidences of radiolucencies noted within the text of this article. Captured in this complaint: corail kla standard stem: implant mispositioned. No patient consequences were noted for the corail kla stem. ".

 
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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
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9451984
MDR Text Key184254919
Report Number1818910-2019-122372
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeFR
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 11/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2019
Is This An Adverse Event Report? No
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 Received11/17/2019
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

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