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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Death (1802); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); No Code Available (3191)
Event Date 02/24/2012
Event Type  Death  
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. (b)(4).
 
Event Description
Literature article "a comparison of a conventional versus a short, anatomical metaphyseal-fitting cementless femoral stem in the treatment of patients with a fracture of the femoral neck" by y-h. Kim and j-h. Oh published by the journal of bone and joint surgery doi:10. 1302/0301-620x. 94b6. 29152 on june 2012 was reviewed for reportability. The purpose: "the purpose of this study was to compare prospectively the clinical and radiological outcomes, mortality and complication rates, and revision rates of cementless thr performed using a short, anatomical metaphyseal-fitting cementless femoral stem versus a conventional diaphyseal-fitting fully porous coating cementless stem in a consecutive group of physically and mentally healthy patients with an acute garden iii or iv14 fracture of the femoral neck. " the article reports includes data from 70 patients who received proxima stems and 70 received aml stems with both utilizing ceramic modular heads and cementless pinnacle acetabular cups with ceramic liners. The article reports: "osseo-integration was seen in all the femoral and acetabular components. No acetabular or femoral component migrated by > 2 mm and no rlls were detected around the porous-coated surface of any acetabular or femoral components on the ap or lateral radiographs. " deaths were noted but were noted one year of operations with two being in short stem group and three were in the conventional stem group but cause of death for those are unknown or clarified. However, one death explained to be caused by pneumonia and septic shock (listed as complications from surgery) occurred one month after the index operation (this particular patient had a short stem who sustained a post-operative peri-prosthetic fracture at the tip of the sem). Complications for post-operative from table iv: urinary tract infection (7 of short stem and 15 of conventional stem); mental status change (7 of short stem and 15 of conventional stem); transfusion reaction (1 of short stem); acute renal failure (1 of short stem and 3 of conventional stem); pneumonia (2 of short stem and 3 of conventional stem) and pulmonary microemboli (11 of conventional stem); also noted are dislocations (1 of short stem and 4 in conventional stem) which were revised or treated with closed reduction; infection treated with intravenous antibiotics). One patient was identified and captured on a linked complaint.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP 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 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8989517
MDR Text Key161930484
Report Number1818910-2019-103692
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received11/06/2019
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: 09/11/2019 Patient Sequence Number: 1
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