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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 Problems Unintended Movement (3026); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2011
Event Type  malfunction  
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 associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(b)(4).
 
Event Description
"literature article entitled, ¿subsidence of the corail femoral component in the elderly.A retrospective radiological review¿ by mohammad faisal, et al, published by hip international (2011), vol.21, no.3, pp.325-329, was reviewed.The aim of our study was to look at the radiological results of uncemented tha in the elderly, to identify the number of patients who developed subsidence within the first year after surgery, whether this was progressive, whether it was related to bone quality, and whether the stems ultimately became stable.All patients were implanted with corail femoral stems.This complaint captures the 13 patients with identified stem migration.Case 1 is captured in (b)(4).Case 2 through case 13 are captured in the attached guidance document and are linked to (b)(4)." (b)(6) yo female patient showed signs of radiologically identified corail stem migration of 8.50-mm.Stem was stable with bony ingrowth at final follow-up.No intervention required and no patient consequences.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP FEMORAL STEM
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9463583
MDR Text Key217440283
Report Number1818910-2019-122907
Device Sequence Number1
Product Code KXA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received12/12/2019
Supplement Dates Manufacturer Received12/26/2019
Supplement Dates FDA Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
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