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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL STEM TRIAL

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DEPUY ORTHOPAEDICS INC US UNK FEMORAL STEM TRIAL Back to Search Results
Catalog Number UNK FEMORAL STEM TRIAL
Device Problems Incorrect Measurement (1383); Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Type  malfunction  
Manufacturer Narrative
Product complaint #
==
> (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The neck trials come with a ring that snaps the head onto the neck, i find that the trials work much better with these rings removed. It allows certainty that the head is fully seated on the neck trial and in a tight hip (big patient) it allows the neck then the head to be put on separately which is much easier.
 
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Brand NameUNK FEMORAL STEM TRIAL
Type of DeviceUNK FEMORAL STEM TRIA
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 Key9286219
MDR Text Key211890171
Report Number1818910-2019-114493
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 company representative,foreig
Type of Report Initial,Followup
Report Date 10/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK FEMORAL STEM TRIAL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2020
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

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