MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® CEMENTLESS FEMORAL COMPONENT 52MM; HIP COMPONENT

Model Number	38PF1052
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, a potential complaint has been received by microport orthopedics legal department.Medical records related to primary surgery mention that x-rays demonstrated right hip degenerative arthritis.There may be a possible failure, which is unknown as no additional information has been received.

• Brand Name: CONSERVE® CEMENTLESS FEMORAL COMPONENT 52MM
• 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: 14427658
• Report Number: 3010536692-2022-00199
• Device Sequence Number: 5487709
• Product Code: JDI
• UDI-Device Identifier: M68438PF10521
• UDI-Public: M68438PF10521
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: 38PF1052
• Device Catalogue Number: 38PF1052
• Device Lot Number: 1480377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/18/2022
• 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 Age: 58 YR
• Patient Sex: Male