MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS HA CUP; HIP COMPONENT

Model Number 38HA4450

Device Problem Output Problem (3005)

Patient Problems Hair Loss (1877); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient underwent bilateral hip resurfacing in two separate surgeries in 2018.Patient has recently contacted the hospital with, complaint of extremely high blood levels of cobalt (200nmol/l) and chromium (300nmol/l) whereas the normal level for a person with an implant is supposed to be less than or equal to 5nmol/l.The patient has been suffering from worsening tinnitus, insomnia, fatigue, hair loss, anxiety and skin issues.The patient is also well aware of the damage to the internal organs due to such toxic levels of these metals in the blood.The surgeries were performed by a canadian surgeon who used to be resident in dubai for more than 15 years.There has not been indicated which patient side is causing the patient to have these issues.No revision surgery has yet been indicated.Right-sided implanted devices are captured under microport orthopedics reference number: (b)(4).

Event Description

Allegedly, patient underwent bilateral hip resurfacing in two separate surgeries in 2018.Patient has recently contacted the hospital with, complaint of extremely high blood levels of cobalt (200nmol/l) and chromium (300nmol/l) whereas the normal level for a person with an implant is supposed to be less than or equal to 5nmol/l.The patient has been suffering from worsening tinnitus, insomnia, fatigue, hair loss, anxiety and skin issues.The patient is also well aware of the damage to the internal organs due to such toxic levels of these metals in the blood.The surgeries were performed by a canadian surgeon who used to be resident in dubai for more than 15 years.There has not been indicated which patient side is causing the patient to have these issues.Right-sided implanted devices are captured under microport orthopedics reference number: (b)(4).Additional information received on 10/13/2022: it was indicated that the patient has been revised.

• Brand Name: CONSERVE® PLUS HA CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15544067
• MDR Text Key: 301189017
• Report Number: 3010536692-2022-00351
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38HA4450
• Device Catalogue Number: 38HA4450
• Device Lot Number: 11012194891675507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2022
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female