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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET, INC. MAGNUM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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BIOMET, INC. MAGNUM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
Reporter states that her son, the pt, was dx with avascular necrosis in 2009 and was unable to walk. She reports that her son underwent what she believes is a right sided hip replacement initially and notes that while her son was still in recovery, his other hip collapsed. Reporter notes that about 3 weeks after initial surgery, the patient underwent replacement of the other hip. Pt since surgery has been in severe pain from the hip downward for several years and it has progressively gotten worse. Pt now ambulates with a cane and has to stand a majority of the day besides sleeping, because sitting has caused him too much pain. Reporter states that on (b)(6) 2020, the pt was dx with chromium poisoning. Reporter notes that pt has been scheduled to explant the devices but has not had them removed as of yet. Reporter notes concern for her son's pain and his premature ambulation difficulties. Of note reporter states that her son's hips are metal-on-metal.
 
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Brand NameMAGNUM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
BIOMET, INC.
MDR Report Key12040628
MDR Text Key257897176
Report NumberMW5102012
Device Sequence Number1
Product Code JDL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/21/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/21/2021 Patient Sequence Number: 1
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