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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM HIP COMPONENT Back to Search Results
Model Number 38AM5004
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Metal Related Pathology (4530)
Event Date 02/03/2022
Event Type  Injury  
Event Description
Allegedly, patients metal ions were high so surgeon wanted to remove the mom articulation. Reporter confirmed that only the head was removed. The other devices were not revised: 38025056 conserveâ® plus cup 50mm id 56mm od beaded , lot: 076351420, qty:1. Pha00272 profemurâ® plasma z stem size 7 , lot: 086357552, qty:1. Pha01204 profemurâ® neck neutral long lot: 086367283, qty:1.
 
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Brand NameCONSERVE® A-CLASS® BFH® HEAD SHORT NECK 50MM
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 Key13586586
MDR Text Key286044209
Report Number3010536692-2022-00051
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 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM5004
Device Catalogue Number38AM5004
Device Lot Number065243289
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/03/2022
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 02/23/2022 Patient Sequence Number: 1
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