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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK Back to Search Results
Catalog Number UNK HIP FEMORAL STEM TRI-LOCK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Bone Fracture(s) (1870)
Event Date 10/20/2019
Event Type  Injury  
Manufacturer Narrative
(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
Article entitled "algorithmic soft tissue femoral release in anterior approach total hip arthroplasty" written morad chughtai, md, linsen t. Samuel, md, mba, alexander j. Acuna, bs and atul f. Kamath, md published by arthroplasty today published online/accepted by publisher november 30, 2019 was reviewed. The article¿s purpose is to report on a novel tha technique that utilizes femoral soft tissue releases. 1059 direct anterior tha cases were reviewed that were completed with the femoral soft tissue releases. Mean age was 65 years old. 48% were male and 52% female. All patients were implants with pinnacle acetabular cups, except two patients with a history of spinal fusion, who received a competitor duel mobility cup. All femoral heads were ceramic. 93% of femoral stems were corail, 3% received trilock, 2% received a cemented summit, and 2% received srom stem. Follow up was conducted for 2 years. Findings: post-op superficial wound closure (1 patient). Post-op calcar fracture (1 patient). Anterior dislocation (1 patient). No cases of radiographic component loosening, deep infection, or deaths. Depuy products: pinnacle cup. Corail stem. Summit stem. Trilock stem. Srom stem/sleeve. Depuy ceramic femoral head. Depuy polyethylene acetabular liner.
 
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Brand NameUNK HIP FEMORAL STEM TRI-LOCK
Type of DeviceFEMORAL 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 Key11163547
MDR Text Key229569475
Report Number1818910-2021-00961
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 health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,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 Catalogue NumberUNK HIP FEMORAL STEM TRI-LOCK
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 Received02/25/2021
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: 01/13/2021 Patient Sequence Number: 1
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