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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 Corroded (1131)
Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative
Product complaint : (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6).
 
Event Description
Litigation alleges that corrosion and friction wear between the implants caused toxic cobalt-chromium debris to be released into the patient's body resulting to injury, pain, inflammation, tissue and bone loss, limited mobility, loss of range of motion, mental anguish and diminished enjoyment of life. A blood-work order confirmed that patient's blood plasma had elevated chromium and cobalt levels.
 
Manufacturer Narrative
(b)(4). No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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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 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380
6103142063
MDR Report Key8239936
MDR Text Key132801837
Report Number1818910-2019-80605
Device Sequence Number1
Product Code KWY
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 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2019 Patient Sequence Number: 1
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