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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 38024652
Device Problems Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, plaintiff received a wright hip system on (b)(6) 2010 for total hip replacement surgery, after implantation of the wright hip system, plaintiff began to experience the painful effects of the product's defective design and manufacture. Plaintiff began suffering persistent pain and decreased mobility, both worsening over time. Plaintiffs wright hip system detached, disconnected, created metallic debris, released metal ions, and/or loosened from plaintiffs acetabulum. On (b)(6) 2021, plaintiff was required to undergo revision surgery to remove and replace defective wright hip system.
 
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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 Key14136710
MDR Text Key289450989
Report Number3010536692-2022-00130
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38024652
Device Catalogue Number38024652
Device Lot Number079867728
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/29/2022
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 04/18/2022 Patient Sequence Number: 1
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