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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK Back to Search Results
Catalog Number UNK HIP STEM TRI-LOCK
Device Problem Malposition of Device (2616)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 09/29/2017
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.
 
Event Description
The literature article, "stem anteversion mismatch to the anatomical anteversion causes loss of periprosthetic bone density after tha" written by shinya hayashi, shingo hashimoto, tomoyuki matsumoto, koji takayama, kotaro nishida, kazunari ishida and ryosuke kuroda published by journal of orthopaedic surgery accepted by publisher on 29 september 2017 was reviewed. The article's purpose was to study the correlations between periprosthetic bone mineral density (bmd) and changing of stem anteversion in patients who underwent tha with a short tapered-wedge stem. Data was compiled from 44 patients who received depuy tri lock bps stem between january 2013 and november 2013 with clinical evaluation performed 24 months postoperatively. The article reports on stem version error and found correlation between anteversion error to gruen zones with bmd loss. The findings indicate that excessive anteversion error causes stem point contact with the femoral bone in the distal portion, leading to proximal periprosthetic bmd loss. Depuy product: trilock stem. Adverse event: bone mineral density loss associated with mispositioned stem (no treatment provided).
 
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Brand NameUNK HIP FEMORAL STEM TRI-LOCK
Type of DeviceFEMORAL 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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10858083
MDR Text Key219563458
Report Number1818910-2020-24894
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP STEM TRI-LOCK
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 Received12/07/2020
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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