MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL 54MM BCH® FEMORAL HEAD; HIP COMPONENT

Model Number	38CH5410
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); Metal Related Pathology (4530)
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
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 (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).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 (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 or Problem 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 (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).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).

• Brand Name: CONSERVE® TOTAL 54MM BCH® FEMORAL HEAD
• 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: 14378221
• Report Number: 3010536692-2022-00193
• Device Sequence Number: 2007593
• Product Code: KXA
• UDI-Device Identifier: M68438CH54101
• UDI-Public: M68438CH54101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 38CH5410
• Device Catalogue Number: 38CH5410
• Device Lot Number: 098606676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 08/12/2022
• 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 Age: 73 YR
• Patient Sex: Male