MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 44MM FEMORAL HEAD; HIP COMPONENT

Model Number	38AC4400
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, 80% tear of gluteus medius with fibers remaining over anterior edge of greater trochanter, bald remainder of greater trochanter.Trunniosis with burnishing of the femoral short neck trunnion at both the head and proximal body interfaces.Stable acetabular, femoral components.Yellow clear serous joint fluid, sent for cell count, culture.Pseudotumor over greater trochanter sent to pathology.Pain, corrosion and suspected metallosis.Non revised products: product id: sphs8000 profemur® r 135mm.Stem size 10 mts.Finish straight/taper/ lot no.: 07493194/ qty: 1.

• Brand Name: CONSERVE® TOTAL A-CLASS® 44MM 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: 17049526
• Report Number: 3010536692-2023-00108
• Device Sequence Number: 7039607
• Product Code: JDL
• UDI-Device Identifier: M68438AC44001
• UDI-Public: M68438AC44001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 08/11/2023

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: 38AC4400
• Device Catalogue Number: 38AC4400
• Device Lot Number: 1398076
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/11/2023
• 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: 71 YR
• Patient Sex: Female