MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01244

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problem Metal Related Pathology (4530)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

The alleged complaint could not be confirmed.Based on the provided information, the patient was revised due to multiple dislocations, which appears to have contributed to fracture of the ceramic femoral head.Additionally, the modular neck was indicated to have worn due to complications concerning the femoral head.These products had been implanted for approximately 198 months at the time of occurrence.The revised products were not returned for investigation.No images, radiographs, or operative notes were provided to confirm this complaint.Review of the dhrs for the known lots indicates that these products were manufactured to specification.Furthermore, there were no other reported complaints involving the known lots.The microport hip systems package insert (150803-8) lists "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity" and "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as possible adverse effects of total hip arthroplasty.It also states, "fatigue fracture of the prosthetic component can occur as a result of trauma, strenuous activity, improper alignment, incomplete implant seating, duration of service, loss of fixation, non-union, or excessive weight." no conclusions can be made from the available information.There were no trends identified per mpo trending procedures.This issue will continue to be monitored through complaint tracking.

Event Description

Allegedly, the patient was revised due to breakage multiple dislocations.Also, pseudotumor was found due to neck wear.The report states that revision is due to multiple dislocations and as a consequence caused head breakage.Due to the head breakage, the neck wore.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• 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: 12277490
• MDR Text Key: 265065634
• Report Number: 3010536692-2021-00427
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2021

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
• Device Operator: Health Professional
• Device Model Number: PHA01244
• Device Catalogue Number: PHA01244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR