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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 101204050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
(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
Pinnacle litigation record received. Litigation alleges friction and wear between cobalt-chromium head and liner causing elevated metal ions and particles in plaintiff blood, tissue and bone resulting to inflammation, mental and emotional injuries, pain and discomfort when ambulating. Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip.
 
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Brand NameTRI-LOCK BPS SZ 5 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 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11164573
MDR Text Key226629975
Report Number1818910-2021-00989
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 Other,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number101204050
Device Lot NumberE1TFG1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2010
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: 01/13/2021 Patient Sequence Number: 1
Treatment
+4 POLYETHYLENE LINER; METAL FEMORAL HEAD 36MM; SIZE 5 TRILOCK FEMORAL STEM
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