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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS CUP HIP COMPONENT Back to Search Results
Model Number 38025056
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, plaintiff had a wright medical hip system in the right hip, by the year 2021 plaintiff developed adverse symptoms including, but not limited to, progressively worsening pain in and around his left and right hip joints, as well as neurologic symptoms including peripheral neuropathy, and tinnitus. Laboratory test results reported in (b)(6) 2021, revealed elevated serum chromium and blood cobalt levels in plaintiff. Dr. (b)(6) noted a pseudotumor and related it to metallosis. Remove the wright medical components, including the profemur® hip system, including the profemur® plus cocr modular neck and the profemur® plasma z stem. Dr. (b)(6) also informed plaintiff that it would be medically necessary to remove and replace the conserve® femoral head and dynasty cup.
 
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Brand NameCONSERVE® PLUS 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 Key14375592
MDR Text Key291507686
Report Number3010536692-2022-00183
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 05/13/2022
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 Number38025056
Device Catalogue Number38025056
Device Lot Number107476061
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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