MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 44MM; HIP COMPONENT

Model Number	38031044
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged complaint is not confirmed.Microport was made aware of this revision through (b)(6) registry data.It was indicated that both resurfacing components were revised due to periprosthetic femoral fracture, which would comprise of the femoral resurfacing head in this case.The revised products have not been returned for investigation.Additionally, no images or operative notes were provided to confirm the complaint.Review of the device history record (dhr) for these lots indicates that these products met all established acceptance criteria throughout the manufacturing process.Review of historical complaint data reveals no lot trends for this issue.This is the first complaint for this lot and issue.These products had been implanted for approximately 142 months until revision.No conclusions regarding the femoral fracture can be made from the available information.The microport hip systems package insert (150803-8) lists "femoral or acetabular perforation or fracture; femoral fracture while seating the device; femoral fracture by trauma or excessive loading, particularly in the presence of poor bone stock" as potential adverse effects of total hip arthroplasty (tha).There is not a trend for this device and incident mode per mpo trending procedures.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, patient was revised due to peri-prosthetic fracture? stem.Revision njr number: (b)(6).Side:r.Primary asa: p2 - mild disease not incapacitating.(b)(4).

• Brand Name: CONSERVE FEMORAL RESURFACING HEAD 44MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11675143
• Report Number: 3010536692-2021-00206
• Device Sequence Number: 3085462
• Product Code: KXA
• UDI-Device Identifier: M684380310441
• UDI-Public: M684380310441
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: Health Professional
• Device Model Number: 38031044
• Device Catalogue Number: 38031044
• Device Lot Number: 096378768
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention