MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT

Model Number	PHA00236
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); 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, the ct report on 08/2021 shows a dislocation of the acetabular part of the hip endoprosthesis, osteolysis and pain.The same result also shows that older radiographs show a significant reaction in the area of the left hip with layers along the left hip prosthesis.Px performed an x-ray on (b)(6) 2021 and the results show that there was thinning of the bone in the acetabular part of the endoprosthesis and in the femur.Loss of mobility due to pain.Products not revised, allegedly revision surgery scheduled for june 2022.
Event or Problem Description
Allegedly, the ct report on 08/2021 shows a dislocation of the acetabular part of the hip endoprosthesis, osteolysis and pain.The same result also shows that older radiographs show a significant reaction in the area of the left hip with layers along the left hip prosthesis.Px performed an x-ray on (b)(6) 2021 and the results show that there was thinning of the bone in the acetabular part of the endoprosthesis and in the femur.Loss of mobility due to pain.Products not revised, allegedly revision surgery scheduled for (b)(6) 2022.

• Brand Name: PROFEMUR® Z STEM
• 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: 14545117
• Report Number: 3010536692-2022-00209
• Device Sequence Number: 5172480
• Product Code: LPH
• UDI-Device Identifier: M684PHA002361
• UDI-Public: M684PHA002361
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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,Followup
• Report Date (Section B): 07/19/2022

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: PHA00236
• Device Catalogue Number: PHA00236
• Device Lot Number: 1468563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 07/19/2022
• 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: 65 YR
• Patient Sex: Female