MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM PLASMA SPRAYED; HIP COMPONENT

Model Number PHA00268

Device Problem Difficult to Remove (1528)

Patient Problems Bone Fracture(s) (1870); Neuropathy (1983); Pain (1994); Tinnitus (2103); Balance Problems (4401); Vitamin Deficiency (4497); Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly pt.Now has elevated metal ions.Originally part of ide / ceramic on metal articulation system clinical study but not any longer.Additional information received on april 19, 2022: patient developed adverse symptoms including, but not limited to, progressively worsening pain in and around his right hip joint, as well as neurologic symptoms including peripheral neuropathy, tinnitus, some balance/coordination issues, a heal fracture as a direct result of those balance/coordination issues, and b12 deficiency.Laboratory test results reported on (b)(6) 2020, revealed elevated serum chromium and blood cobalt levels in patient.On (b)(6) 2021, patient had a revision surgery performed on his right hip by (b)(6), m.D., at (b)(6) clinic (b)(6) hospital, (b)(6).Early in his (b)(6) 2021, operative report, dr.(b)(6) noted, "metallosis debris at the external rotators." after removal of the conserve® femoral head from the profemur® plus modular neck, dr.(b)(6) noted "a fair amount of black corrosion discoloration at the taper on both components." in the (b)(6) 2021, revision surgery, dr.(b)(6), removed the wright medical profemur® hip system, including the profemur® plus cocr modular neck and profemur® plasma z stem, as well as the conserve® femoral head, that had been implanted in plaintiff's right hip in 2010, were removed, and replaced with a femoral stem, femoral head, and a dual mobility bearing, all devices from zimmer biomet.In the same revision surgery, the instrument used to extract the stem had a failure and it couldn't be used.Therefore, an extended trochanteric osteotomy was necessary.This problem has been captured and investigated under microport orthopedics incident number: (b)(4).

Event Description

Allegedly pt.Now has elevated metal ions.Originally part of ide / ceramic on metal articulation system clinical study but not any longer.Additional information received on april 19, 2022: patient developed adverse symptoms including, but not limited to, progressively worsening pain in and around his right hip joint, as well as neurologic symptoms including peripheral neuropathy, tinnitus, some balance/coordination issues, a heal fracture as a direct result of those balance/coordination issues, and b 12 deficiency.Laboratory test results reported on may 26, 2020, revealed elevated serum chromium and blood cobalt levels in patient.On (b)(6) 2021, patient had a revision surgery performed on his right hip by (b)(6).Early in his (b)(6) 2021, operative report, dr.(b)(6) noted, "metallosis debris at the external rotators." after removal of the conserve® femoral head from the profemur® plus modular neck, dr.Jones noted "a fair amount of black corrosion discoloration at the taper on both components." in the (b)(6) 2021, revision surgery, dr.(b)(6), removed the wright medical profemur® hip system, including the profemur® plus cocr modular neck and profemur® plasma z stem, as well as the conserve® femoral head, that had been implanted in plaintiff's right hip in 2010, were removed, and replaced with a femoral stem, femoral head, and a dual mobility bearing, all devices from zimmer biomet.In the same revision surgery, the instrument used to extract the stem had a failure and it couldn?t be used.Therefore, an extended trochanteric osteotomy was necessary.This problem has been captured and investigated under microport orthopedics incident number: (b)(4).

• Brand Name: PROFEMUR® Z STEM PLASMA SPRAYED
• 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: 15105288
• MDR Text Key: 296605343
• Report Number: 3010536692-2022-00256
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684PHA002681
• UDI-Public: M684PHA002681
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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: Health Professional
• Device Model Number: PHA00268
• Device Catalogue Number: PHA00268
• Device Lot Number: 0301041135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2022
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 08/12/2022
• 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: 73 YR
• Patient Sex: Male