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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 38025460
Device Problems Material Disintegration (1177); Loss of Osseointegration (2408)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Case number: (b)(4). Allegedly, px began to experience pain, decreased mobility, metal debris, loosening of the acetabulum and metallosis.
 
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
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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 Key14134956
MDR Text Key289430391
Report Number3010536692-2022-00129
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,Followup
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 Number38025460
Device Catalogue Number38025460
Device Lot Number117481330
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/22/2022
Date Manufacturer Received03/22/2022
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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