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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM HIP COMPONENT Back to Search Results
Model Number 38AM4035
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Allegedly, patient was revised due to unknown reasons.
 
Manufacturer Narrative
The alleged complaint could not be confirmed. The provided incident report states that this patient was revised resulting from "surgeon preference regarding patient condition. " microport post market quality contacted the reporting sales representative regarding the possible causes concerning the described patient condition, but the sales representative did not provide any additional information related to this event. Review of the device history record (dhr) for this lot indicates that these products met all established acceptance criteria throughout the manufacturing process. Review of historical complaint data reveals no lot trends for any complaint modes. There is not enough information to investigate this complaint. No information regarding a product failure or any specific complications were made available. This investigation will be reopened if additional information is received.
 
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Brand NameCONSERVE® A-CLASS® BFH® HEAD LONG NECK 40MM
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 Key12908463
MDR Text Key281656628
Report Number3010536692-2021-00571
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM4035
Device Catalogue Number38AM4035
Device Lot Number05113488501805518
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2021
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

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