MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD MEDIUM NECK 50MM; HIP COMPONENT

Model Number	38AM5000
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	Reaction (2414); Metal Related Pathology (4530)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, due to doubt of armd (adverse reaction to metal debris) which is a revision because it is a pseudotumor after total hip arthroplasty.The surgeon, dr.(b)(6), mentioned that this can occur with metal on metal devices.The surgeon requested to measure the amount of implant wear at the following junctions: cup + head, head + neck, and neck + stem.The interface between the femoral head and the neck and the interface between the stem and neck have black discoloration.The articulating surface of the femoral head and cup visually looks good.(b)(6).
Event or Problem Description
Allegedly, the patient was revised due to a suspected adverse tissue reaction to metal debris (armd) and the presence of a pseudotumor.The surgeon indicated that such complications can occur with metalon- metal (mom) tha constructs and has requested to assess the wear of the products at the following junctions: acetabular cup and femoral head, femoral head and femoral neck, and femoral neck and femoral stem.The surgeon describes the presence of "black discoloration" at the interfaces between the femoral head and the femoral neck as well as between the femoral neck and femoral stem.Additionally, the surgeon described the articulating surfaces of the femoral head and acetabular cup as "visually looks good." japan- (b)(4).
Additional Manufacturer Narrative
Updated incident description, initial reporter information, adverse event problem and investigation codes.

• Brand Name: CONSERVE A-CLASS BFH HEAD MEDIUM NECK 50MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10602906
• Report Number: 3010536692-2020-00634
• Device Sequence Number: 3669931
• Product Code: KWA
• UDI-Device Identifier: M68438AM50001
• UDI-Public: M68438AM50001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: 38AM5000
• Device Catalogue Number: 38AM5000
• Device Lot Number: 028552368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 100