MAUDE Adverse Event Report: HIP; PROSTHESIS HIP SEMI-CONSTRAINED METAL UNCEMENTED ACETABULAR COMPONENT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Inflammation (1932); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Metal on metal hip replacement to right hip in 2008, left hip 2010.Had uncomfortable, unstable problems with left hip.In 2018 started having strange health issues.Problems with heart, lungs and skin.Had fluid build up on hips and left hip dislocated.Had to have left hip revision and dr described damaged to surrounding bone due to metallosis.Fda safety report id# (b)(4).

• Brand Name: HIP
• Type of Device: PROSTHESIS HIP SEMI-CONSTRAINED METAL UNCEMENTED ACETABULAR COMPONENT
• MDR Report Key: 9540160
• MDR Text Key: 173647455
• Report Number: MW5091995
• Device Sequence Number: 2
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 70