MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® HEAD; HIP COMPONENT

Model Number	38AM5204
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient started to experience pain in or around his left hip joint in (b)(6) 2019.Tests for cobalt blood levels drawn on (b)(6) 2020, showed an elevated cobalt level of 4.9 in the results received on (b)(6) 2020.On (b)(6) 2020, patient was diagnosed by dr.(b)(6) to have corrosion/metallosis wright medical femoral stem and recommended a revision surgery.On (b)(6) 2020, patient's left hip was revised, resulting in removal and replacement of the previously implanted conserve hip.The operative note from the (b)(6) 2020, revision procedure references: failed left total hip replacement with pseudotumor and metallosis.? it was evident at this point that the large pseudotumor, which had been diagnosed by mri had tented the gluteus maximus.It measured approximately 4 x 4 cm.It was attached to the lateral proximal trochanter.? significant necrotic capsule and tissue.? corrosion extending from the head.?.

• Brand Name: CONSERVE® TOTAL A-CLASS® HEAD
• 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: 13719745
• Report Number: 3010536692-2022-00072
• Device Sequence Number: 5970012
• Product Code: JDL
• UDI-Device Identifier: M68438AM52041
• UDI-Public: M68438AM52041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: Health Professional
• Device Model Number: 38AM5204
• Device Catalogue Number: 38AM5204
• Device Lot Number: 036313050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/10/2022
• 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