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

Model Number	38AM4600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, an mri of the patient's left hip taken due to pain on (b)(6) 2021, this showed a periarticular cyst, suggestive of metallosis.The metal ion levels extracted on (b)(6) 2022 were found to be cr = 3.4 and co = 3.8 which increased with respect to the metal ions extracted on may 14, 2021, which were cr= 2.2 and co= 2.9.

• Brand Name: CONSERVE® A-CLASS® BFH® HEAD MEDIUM NECK 46MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18627704
• Report Number: 3010536692-2024-00069
• Device Sequence Number: 20856080
• Product Code: KWA
• UDI-Device Identifier: M68438AM46001
• UDI-Public: M68438AM46001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• 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): 02/01/2024

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: 38AM4600
• Device Catalogue Number: 38AM4600
• Device Lot Number: 128747412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 02/01/2024
• 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