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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 38HA4248
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Osteolysis (2377); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to lysis-stem/lysis-socket/adverse soft tissue reaction to particulate debris. The cup, head, stem and neck have been revised from patient. Revision njr number: (b)(4), side:r, 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 Key14021433
MDR Text Key288677186
Report Number3010536692-2022-00100
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 Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38HA4248
Device Catalogue Number38HA4248
Device Lot Number87442058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/15/2022
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 04/06/2022 Patient Sequence Number: 1
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