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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-04-030
Device Problems Inadequacy of Device Shape and/or Size (1583); Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).
 
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
Dr complained that the broach was sitting significantly lower than the final implant. He used another stem and it did the same thing so he requested a 3rd implant.
 
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Brand NameTRI-LOCK BPS SZ 3 STD OFFSET
Type of DeviceTRILOCK HIP STEM : HIP 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
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9296334
MDR Text Key175498509
Report Number1818910-2019-115221
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012-04-030
Device Catalogue Number101204030
Device Lot NumberJ5115U
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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