MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® ROUGHENED DISTAL STEM, TAPERED; HIP COMPONENT

Model Number PPW38023

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Fever (1858); Pain (1994)

Event Date 04/28/2019

Event Type  Injury  

Event Description

Allegedly, on (b)(6) 2019, while in her home sitting in a rest position, patient felt a sudden pain in the hip with associated functional impotence.The following day she was taken to the (b)(6) institute and underwent a visit and radiological examination: the prosthetic stem breakage at the proximal third.(right leg).Patient was therefore forced to undergo a new arthroplasty revision surgery on the right femoral stem with metal osteosynthesis with cerclage on (b)(6) 2019.The operation was followed by a long hospitalization that lasted until (b)(6) 2019 due to the onset of persistent fever.Following her discharge, patient was forced to undergo further hospitalizations for three episodes of dislocation of the right hip prosthesis.Patient has completely lost the ability to walk, if not for short stretches and with the help of a walker and a person to help her.

Manufacturer Narrative

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

Event Description

Allegedly,on (b)(6) 2019, while in her home sitting in a rest position, patient felt a sudden pain in the hip with associated functional impotence.The following day she was taken to the (b)(6) orthopedic institute and underwent a visit and radiological examination: the prosthetic stem breakage at the proximal third.(right leg) patient was therefore forced to undergo a new arthroplasty revision surgery on the right femoral stem with metal osteosynthesis with cerclage on (b)(6) 2019.The operation was followed by a long hospitalization that lasted until (b)(6) 2019 due to the onset of persistent fever.Following her discharge, patient was forced to undergo further hospitalizations for three episodes of dislocation of the right hip prosthesis.Patient has completely lost the ability to walk, if not for short stretches and with the help of a walker and a person to help her.After further review of this event, reliability engineering has been able to determine on (b)(6) 2022 that the cup, liner and head are not mpo products.

Manufacturer Narrative

Sectio b.5: additional information in description / section f.5: awareness date update.

• Brand Name: PROFEMUR® ROUGHENED DISTAL STEM, TAPERED
• 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: 15052178
• MDR Text Key: 296139526
• Report Number: 3010536692-2022-00252
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PPW38023
• Device Catalogue Number: PPW38023
• Device Lot Number: 1604621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2022
• Date Manufacturer Received: 06/23/2022
• 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: 89 YR