MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 46MM; HIP COMPONENT

Model Number	38AM4604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient experienced pain in his hip and testing revealed high cobalt levels that could lead to cobalt poisoning.
Event or Problem Description
Allegedly, patient experienced pain in his hip and testing revealed high cobalt levels that could lead to cobalt poisoning.Additional information received on 07/11/2022: patient underwent index surgery on his right hip on (b)(6) 2006.Patient subsequently underwent revision surgery on (b)(6) 2019.He alleges cocr corrosion at the neck/stem junction, but he did not receive a cocr neck or stem.He does allege elevated metal ions, and he did receive mom head/cup devices.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 46MM
• 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: 11139166
• Report Number: 3010536692-2021-00008
• Device Sequence Number: 11707346
• Product Code: KWA
• UDI-Device Identifier: M68438AM46041
• UDI-Public: M68438AM46041
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 38AM4604
• Device Catalogue Number: 38AM4604
• Device Lot Number: 065226086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 07/19/2022
• 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 Sex: Male