MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® FEMORAL RESURFACING HEAD 44MM; HIP COMPONENT

Model Number	38031044
Health Effect - Clinical Codes	Hair Loss (1877); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem 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.Left-sided implanted devices are captured under microport orthopedics reference number: (b)(4).
Additional Manufacturer Narrative
Section b.5 additional information in description / section d.6b: explant date added / section e initial reporter has been updated.
Event or Problem 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 (b)(6) 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.Left-sided implanted devices are captured under microport orthopedics reference number: (b)(4).Additional information received on 10/13/2022: it has been confirmed that revision surgery for the left side have been already performed but there has not been a revision surgery performed for the right side.They are awaiting a date for right hip revision.Additional information received on 11/20/2024: it was indicated that the patient has been revised.

• Brand Name: CONSERVE® FEMORAL RESURFACING HEAD 44MM
• Common Device Name: 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: 15544086
• Report Number: 3010536692-2022-00352
• Device Sequence Number: 5593859
• Product Code: KXA
• UDI-Device Identifier: M684380310441
• UDI-Public: M684380310441
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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
• Operator of Device: Other
• Device Model Number: 38031044
• Device Catalogue Number: 38031044
• Device Lot Number: 1733070
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female