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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS HA CUP HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS HA CUP HIP COMPONENT Back to Search Results
Model Number 38HA5460
Device Problems Corroded (1131); Material Discolored (1170); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Neuropathy (1983); 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 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).
 
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Brand NameCONSERVE® PLUS HA CUP
Type of DeviceHIP 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 Key14375645
MDR Text Key291509551
Report Number3010536692-2022-00184
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38HA5460
Device Catalogue Number38HA5460
Device Lot Number0501095300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/19/2022
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 05/12/2022 Patient Sequence Number: 1
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