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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL LONG COBALT CHROME HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL LONG COBALT CHROME HIP COMPONENT Back to Search Results
Model Number PHAC1204
Device Problem Break (1069)
Patient Problem Unspecified Infection (1930)
Event Date 01/28/2022
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
Allegedly, patient was ex domo (prof r implantation in another hospital). Prosthesis pseudo- arthritic, broken stem below proximal part. Regarding a low grade infect as differential diagnosis, stem and cup explanted in (b)(6) hospital. Bfarm case number: (b)(4).
 
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Brand NamePROFEMUR® NECK NEUTRAL LONG COBALT CHROME
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 Key13640043
MDR Text Key286423386
Report Number3010536692-2022-00060
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K091423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPHAC1204
Device Catalogue NumberPHAC1204
Device Lot Number1616373
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/11/2022
Date Manufacturer Received02/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 03/01/2022 Patient Sequence Number: 1
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