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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 Problem Noise, Audible (3273)
Patient Problem Metal Related Pathology (4530)
Event Date 01/31/2021
Event Type  Injury  
Event Description
Allegedly the patient report "clicking and popping" sounds from his right hip, the dr noted audible and palpable popping of the right hip with flexion, and the radiographic images revealed that the wright medical conserve hip failed and the patient was suffering from elevated cobalt chrome levels.
 
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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 Key14690792
MDR Text Key294040953
Report Number3010536692-2022-00219
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38025460
Device Catalogue Number38025460
Device Lot Number114115097
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/25/2022
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 06/14/2022 Patient Sequence Number: 1
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