MAUDE Adverse Event Report: UNKNOWN REPLACEMENT HIP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Toxicity (2333)

Event Type  Injury  

Event Description

Manufacturers of hip and knee replacement products using toxic metals to cut cost at risk of extreme harm and death.The product is coated to slow down the toxicity ¿causing food and drud dmnin¿ to have false date, betty vogel danville ny suffered, required nursing home care and second surgery as product leaked titanium poison causing it to fail.Company issued emergency service placing in another coated titanium chip.Patient is dead from bad product used to cover financial fraud records are with (b)(6).Victim lost his mother and father died within year of her death because of grief.Fda safety report id # (b)(4).See scanned pgs.

• Brand Name: REPLACEMENT HIP
• Type of Device: REPLACEMENT HIP
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9516060
• MDR Text Key: 172725082
• Report Number: MW5091853
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/20/2019
• 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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability