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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ACTIS (HIP); PROSTHESIS, HIP, HEMI, FEMORAL

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DEPUY ORTHOPAEDICS, INC. ACTIS (HIP); PROSTHESIS, HIP, HEMI, FEMORAL Back to Search Results
Device Problems Break (1069); Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 05/03/2019
Event Type  Injury  
Event Description
Caller called to report that he had to have his hip implant revised due to unintended movement related to the new hip design.On (b)(6) 2019 the reporters femur broke he screamed in pain.On (b)(6) 2019, the femur was repaired with a plate.In (b)(6) 2019 the reporters femur and the plate broke.The reporters doctor told him that he has had two other hips of that same design fail within ninety days of his original implant date.On (b)(6) reporter had a revisional hip implant by stryker placed however, the reporter got an infection and had it removed on (b)(6) 2019.Currently, the reporter has a antimicrobial hip spacer implanted and is waiting for the infection to heal.Reporter stated that this his cost missed time at work; he is self employed and having financial distress not receiving any income.That he has had to use funds in his 401k retirement savings to provide for him and his family.
 
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Brand Name
ACTIS (HIP)
Type of Device
PROSTHESIS, HIP, HEMI, FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
MDR Report Key9315950
MDR Text Key166354376
Report NumberMW5091012
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/12/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age62 YR
Patient Weight109
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