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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Thrombosis (2100); Tissue Damage (2104); Injury (2348); No Code Available (3191)
Event Date 08/29/2018
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.
 
Event Description
The literature article entitled, "do postoperative results differ in a randomized trial between a direct anterior and a direct lateral approach in tha" written by knut erik mjaaland md, kjetil kivle md, svein svenningsen md, phd, and lars nordsletten md, phd published by clinical orthopaedics and related research made available online on 29 august 2018 was reviewed. The article's purpose was to compare the direct anterior approach with the direct lateral approach to tha with respect to various outcomes. Data was compiled from 164 patients with follow ups at 3, 6, 12 and 24 months including harris hop score, 6 minute walk distance test, trendelenburg test and oxford hip score. All patients received depuy products with exception of the unidentified cement manufacturer. Depuy products: cemented all poly marathon cup, uncemented corail stem, ceramic head, ceramic head. Adverse events reported: nerve injury (some self resolved, some treated and one permanent but no motor function loss), avulsion of the greater trochanter (treated with cable wire during primary with no sequelae), infection (treated by antibiotics, revision), detachment of released part of gluteus medius (treated by surgical intervention), dvt (treated by warfarin), pulmonary embolus (treated by warfarin).
 
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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)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10844646
MDR Text Key216397604
Report Number1818910-2020-24695
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeNO
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,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1
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