MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 5; HIP COMPONENT

Model Number	PRTL0025
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/04/2016
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
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 (b)(6) 2021 confirming that components were not revised.
Additional Manufacturer Narrative
Section b.5: additional information in description.
Event or Problem 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 (b)(6) 2021 confirming that components were not revised.Sae# 051-027l-1, patient has been experiencing left hip pain.He had psoas tendon release in 2018 (event 1) 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.

• Brand Name: PROFEMUR® TL STEM SZ 5
• 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: 12771850
• Report Number: 3010536692-2021-00560
• Device Sequence Number: 14938063
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00251
• UDI-Public: M684PRTL00251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060358
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2022

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: Other
• Device Model Number: PRTL0025
• Device Catalogue Number: PRTL0025
• Device Lot Number: 1506168
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021; 10/21/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 01/06/2022; 12/14/2022
• 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 Sex: Male