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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 38021154
Device Problem Loss of Osseointegration (2408)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
See investigation attached.
 
Event Description
Allegedly, patient was revised due to aseptic loosening socket. Revision njr number: (b)(4), side:l, primary asa: p1 - fit and healthy.
 
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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 Key10337941
MDR Text Key200803601
Report Number3010536692-2020-00510
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38021154
Device Catalogue Number38021154
Device Lot Number10351851
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2020
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/29/2020 Patient Sequence Number: 1
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