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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-04-040
Device Problem Migration (4003)
Patient Problems Pain (1994); Joint Laxity (4526)
Event Date 08/10/2021
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
It was reported that the patient presented with increasing hip pain and instability. Trilock stem is noted to have subsided at some point in time. Stem was well fixed and difficult to remove. 40mm +5 metal head was also explained (product and lot numbers could not be discerned). Cup and liner reminder insitu. Doi: (b)(6) 2008, dor: (b)(6) 2021, right hip.
 
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Brand NameTRI-LOCK BPS SZ 4 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
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12384224
MDR Text Key268683456
Report Number1818910-2021-18880
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012-04-040
Device Catalogue Number101204040
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 Received09/21/2021
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

Patient Treatment Data
Date Received: 08/30/2021 Patient Sequence Number: 1
Treatment
TRI-LOCK BPS SZ 4 STD OFFSET; UNK 40+5 METAL HEAD
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