MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 4; HIP COMPONENT

Model Number PRTL0024

Device Problems Corroded (1131); Material Frayed (1262)

Patient Problems Neuropathy (1983); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, on (b)(6), 2012, patient had a wright medical artificial hip implanted in the right side of his body in a procedure known as a total hip arthroplasty {tha).Patient's (b)(6)2012, hip implant surgery was performed at the hospital for joint diseases, new york, new york.After his initial recovery from the (b)(6) 2012, hip surgery, for several years patient's wright medical artificial hip performed as expected, and the pain and disability patient had experienced in his right hip prior to his (b)(6) 2012, hip replacement surgery had been substantially relieved.Late in the year 2019 patient developed adverse symptoms including, but not limited to, progressively worsening pain in and around his right hip joint.Patient's orthopedic surgeon, subsequently, in the year 2021, informed patient that in his medical judgment it was advisable to undergo a right hip revision surgery to remove the profemur® hip system, including the profemur® plus cocr modular neck and the profemur® tl femoral stem, and replace it with a hip stem system of a different medical device manufacturer, zimmer-biomet.Surgeon also informed patient that it would be medically necessary to remove and replace the conserve® femoral head.On (b)(6) 2020, patient had a revision surgery performed on his right hip.Due to micromotion and fretting corrosion of the oblong taper of the profemur® plus cocr modular neck where it seated in the pocket of the stem, the profemur® plus cocr modular neck implanted in patient's right hip corroded, causing physical injury to patient.Patient sustained injuries and damages including, but not limited to, pain, suffering, disability, and physical impairment, as well as neurologic symptoms including peripheral neuropathy, tinnitus, balance/coordination issues, a heal fracture as a direct result of those balance/coordination issues, and b 12 deficiency.It is also indicated that patient's profemur® plus cocr modular neck had micromotion, fretting corrosion, galvanic corrosion, and fracture.It is not indicated whether the shell and liner components were revised or left in place.

• Brand Name: PROFEMUR® TL STEM SZ 4
• 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: 15312880
• MDR Text Key: 298815185
• Report Number: 3010536692-2022-00297
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PRTL00241
• UDI-Public: M684PRTL00241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

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: PRTL0024
• Device Catalogue Number: PRTL0024
• Device Lot Number: 1422312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2022
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 10/21/2022
• 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