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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 0 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 0 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-14-005
Device Problems Osseointegration Problem (3003); Migration (4003)
Patient Problem Inadequate Osseointegration (2646)
Event Date 03/14/2022
Event Type  Injury  
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
Patients was revised due to loosening. Stem subsided and became loose, so surgeon removed stem and head and replaced with an actis and a new femoral head. Doi: (b)(6) 2018, dor: (b)(6) 2022, affected side: right hip.
 
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Brand NameTRI-LOCK BPS SZ 0 HI 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
amy hendrickson
700 orthopaedic dr.
warsaw, IN 46581-0988
5743674841
MDR Report Key13949771
MDR Text Key288191430
Report Number1818910-2022-05764
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012-14-005
Device Catalogue Number101214005
Device Lot Number236562
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/30/2022 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM -2); TRI-LOCK BPS SZ 0 HI OFFSET
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