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

Model Number PHA01202

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sae# (b)(4).Allegedly, the patient started having lt hip pain 3 weeks after surgery.Multiple attempts to relief the pain with corticosteroid injections intra-articular with no success.The patient underwent a surgical intervention for release of the psoas tendon on (b)(6) 2018.The pain and weakness in the left thigh is still persistent.Additional information from clinical received on 26/10/2021 confirming that components were not revised.

Event Description

Sae# 051-027l-1.Allegedly, the patient started having lt hip pain 3 weeks after surgery.Multiple attempts to relief the pain with corticosteroid injections intra-articular with no success.The patient underwent a surgical intervention for release of the psoas tendon on (b)(6) 2018.The pain and weakness in the left thigh is still persistent.Additional information from clinical received on 26/10/2021 confirming that components were not revised.Sae# 051-027l-2.Allegedly, patient has been experiencing left hip pain.He had psoas tendon release in 2018 with no relief.Pain has persisted and on (b)(6) 2022, he underwent surgical exploration of the hip, synovectomy and revision of the femoral head and excision of heterotopic ossification.He was discharged the same day.

Manufacturer Narrative

Section b.5: additional information in description.

• 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: 12771847
• MDR Text Key: 280506995
• Report Number: 3010536692-2021-00559
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012021
• UDI-Public: M684PHA012021
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01202
• Device Catalogue Number: PHA01202
• Device Lot Number: 1528939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2021
• Date Manufacturer Received: 10/21/2021
• 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 Sex: Male