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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 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 101214050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); Loss of Range of Motion (2032); Osteolysis (2377); No Code Available (3191)
Event Date 05/15/2017
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
After review of medical records, the patient was revised to address chronic instability, osteolysis, recurrent dislocation and chronic infection. Operative findings include a copious amount of hematoma and metal stained soft tissue with the appearance of pseudotumor in the pericapsular tissue. There was severe proximal femoral osteolysis with erosion of the proximal femur at the level of the lesser trochanter. Upon removal of the femoral stem, a fracture occurred around the trochanter region. A cerclage cable was placed. The metal-on-metal liner was found to be cold-welded to the cup and could not be disengaged. There was also severe osteolysis on the acetabulum. Notes from visits to the physician indicate patient was also having limited range of motion and gait instability. Non-depuy antibiotic spacers were placed. Doi: (b)(6) 2009; dor: (b)(6) 2017; (right hip).
 
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Brand NameTRI-LOCK BPS SZ 5 HI OFFSET
Type of DeviceTRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8798389
MDR Text Key151304558
Report Number1818910-2019-98546
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number101214050
Device Lot NumberDG3DD1000
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 Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2009
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: 07/17/2019 Patient Sequence Number: 1
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