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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 8 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 8 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-04-080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Ischemic Heart Disease (2493); Ambulation Difficulties (2544); Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. (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
Ppf, pfs and medical records received. Ppf has no allegation. Pfs alleges pain, gain weight, dm, heart issues, walking difficulty, decrease rom, metallosis and patient suspect metal in blood caused memory impairment. After review of medical records, no revision was scheduled due to diabetes and heart condition as well as throat issue, patient could not be intubated and that a revision surgery would be out of the question. Patient also reported concerns about metallosis. Doi: (b)(6) 2008. Dor: none reported. Left hip.
 
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Brand NameTRI-LOCK BPS SZ 8 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 Key11661002
MDR Text Key245350745
Report Number1818910-2021-07853
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1012-04-080
Device Catalogue Number101204080
Device Lot NumberCK7J31000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2008
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: 04/13/2021 Patient Sequence Number: 1
Treatment
12/14 ARTICUL 40MM M SPEC-2; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 8 STD OFFSET
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