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

Model Number PHA00236

Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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 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
• Type of Device: 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
• MDR Text Key: 292955271
• Report Number: 3010536692-2022-00209
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684PHA002361
• UDI-Public: M684PHA002361
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/30/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female