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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE PLUS HA CUP HIP COMPONENT Back to Search Results
Model Number 38HA5056
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to other| adverse soft tissue reaction to particulate debris. Revision njr number: (b)(4), side: l. Primary asa: p2 - mild disease not incapacitating.
 
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Brand NameCONSERVE PLUS HA 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 Key12315346
MDR Text Key266297447
Report Number3010536692-2021-00439
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38HA5056
Device Catalogue Number38HA5056
Device Lot Number108632968
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/14/2021
Event Location No Information
Date Manufacturer Received07/14/2021
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: 08/12/2021 Patient Sequence Number: 1
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