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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Date 01/01/2004
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. (b)(4).
 
Event Description
The literature article entitled, "thigh pain in primary total hip arthroplasty" written by carlos lavernia, md, michele d'apuzzo, md, victor hernandez, md, and david lee, phd published by the journal of arthroplasty vol. 19 no. 7 suppl. 2 2004 was reviewed. The article's purpose to assess the effects of material composition in the development of thigh pain after primary cementless total hip arthroplasty in a tapered stem series. Data was compiled from 241 patients who received depuy tha products between november 1997 and june 2001. All components were press-fitted and cups had supplemental fixation screws with poly liners. All stems were trilock stems that were cobalt-chrome-molybdenum prior to 2000 and titanium-aluminum-vanadium in year 2000 and after. Patients age range 18-93 and were followed for a minimum of 2 years. Depuy products utilized: trilock stems, femoral head, poly liner, pressfit cup, cup fixation screws. Adverse events: infection (treated with revision), periprosthetic femur fracture (treatment not clarified), thigh pain (treatment not clarified), stems in valgus or varus positions (treatment not clarified), pedestal formations in femur(treatment not clarified) the article does not provide adequate information to determine accurate quantities.
 
Manufacturer Narrative
(b)(4) to capture medical device removal.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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
6107428552
MDR Report Key9397347
MDR Text Key185006531
Report Number1818910-2019-119102
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,Followup
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received12/12/2019
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: 12/02/2019 Patient Sequence Number: 1
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