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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 Migration (4003)
Patient Problem Ambulation Difficulties (2544)
Event Date 09/29/2020
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.
 
Event Description
Literature article entitled, ¿higher rate of complications with uncemented compared to cemented total hip arthroplasty for displaced intracapsular hip fractures: a randomised controlled trial of 50 patients¿ by n.D.Clement, et al, published by european journal of orthopaedic surgery and traumatology (2020), https://doi.Org/10.1007/s00590-020-02808-x, 9 pages, was reviewed.The primary aim of this study was to compare the functional outcome of uncemented with cemented total hip arthroplasty (tha) for displaced intracapsular hip fractures in 50 patients with poor bone quality implanted between september 2009 and december 2010.Requirements for inclusion in the study was the need for a tha to treat an acetabular hip fracture.The cemented group was implanted with competitor products.Depuy products captured in this complaint: the uncemented group was implanted with a depuy tha consisting of a pinnacle cup and corail stem.The manufacturer of the liners and heads used were not provided but are assumed to be depuy.Results: this complaint will capture the adverse events associated with 6 specific patients.Patient 19: patient had noted femoral stem subsidence with difficulty walking 4 months after index surgery.Patient did not receive any treatment.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.
 
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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 Key11013705
MDR Text Key222103447
Report Number1818910-2020-27033
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
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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