MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT

Model Number	26000004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, intra-articular metallosis secondary to trunnion wear, osteolysis, pseudotumor and proximal peri-prosthetic fracture.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: CERAMIC FEMORAL HEAD
• 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: 18673233
• Report Number: 3010536692-2024-00076
• Device Sequence Number: 6155585
• Product Code: MRA
• UDI-Device Identifier: M684260000041
• UDI-Public: M684260000041
• Combination Product (Y/N): N
• PMA/510(K) Number: P030027
• 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,Followup
• Report Date (Section B): 07/10/2024

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: Other
• Device Model Number: 26000004
• Device Catalogue Number: 26000004
• Device Lot Number: 0101030296
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 07/10/2024
• 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 Age: 45 YR
• Patient Sex: Female