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

Model Number PRTL0025

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 01/26/2022

Event Type  Injury  

Event Description

Allegedly, the patient was complaining of pain and crp levels were high, so we suspected infection and planned to remove the tl, but as it turned out, there was no infection in the test results.During the op, the neck could not be removed from the stem no matter what i did, and as a result, the entire stem was removed.The affected area was clean and there was no loosening on the cup side.There was no evidence of bone on growth at the proximal plasmapheresis coating.(b)(4).

Manufacturer Narrative

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

• Brand Name: PROFEMUR® TL STEM SZ 5
• 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: 13534768
• MDR Text Key: 285614672
• Report Number: 3010536692-2022-00044
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00251
• UDI-Public: M684PRTL00251
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060358
• 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: 05/19/2022

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: Other
• Device Model Number: PRTL0025
• Device Catalogue Number: PRTL0025
• Device Lot Number: 1755470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2022
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 05/20/2022
• 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: 71 YR
• Patient Sex: Male