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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 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-14-040
Device Problems Fracture (1260); Migration (4003)
Patient Problem Fall (1848)
Event Date 06/17/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint #
==
> (b)(4).
 
Event Description
It was reported that on (b)(6), 2022, the patient underwent the bipolar hip arthroplasty with the trilock for the right hip joint. The surgery was completed successfully without any surgical delay. After the surgery, the fracture of the femoral stem occurred due to multiple falls at the hospital, and the stem sank. Therefore, a revision surgery was performed on (b)(6),2022. The implants were removed, and the stem was replaced with other company¿s stem. No further information is available.
 
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Brand NameTRI-LOCK BPS SZ 4 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)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
MDR Report Key14914793
MDR Text Key295236850
Report Number1818910-2022-12288
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number1012-14-040
Device Catalogue Number101214040
Device Lot NumberJD8141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/05/2021
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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