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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS CUP HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS CUP HIP COMPONENT Back to Search Results
Model Number 3802-4854
Device Problem Noise, Audible (3273)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Orig. Surg. (b)(6) 2008. (b)(6) yrs old. Allegedly mr. (b)(6) total hip (right) squeaks intermittently. Dr. (b)(6) states the hip seems to clatter/rub during rom. Update: cup, head, and neck received by microport post market quality on 23 may 2018. The stem was not returned. The explant date is unknown.
 
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Brand NameCONSERVE(R) 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 Key11015622
MDR Text Key221733336
Report Number3010536692-2020-00771
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
Reporter Occupation
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3802-4854
Device Lot Number107471785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/23/2018
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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