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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 3; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR® TL STEM SZ 3; HIP COMPONENT Back to Search Results
Model Number PRTL0023
Device Problems Break (1069); Corroded (1131)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, revision surgery was necessary because the device failed due to corrosion at the head-neck junction and neck-stem junction.The patient experience fracture at the stem and modular neck junction, metallosis, tissue reaction, pseudotumor, pain, loss of mobility and corrosion.
 
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
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Brand Name
PROFEMUR® TL STEM SZ 3
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
rachael wise
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key19203229
MDR Text Key341287937
Report Number3010536692-2024-00279
Device Sequence Number1
Product Code JDI
UDI-Device IdentifierM684PRTL00231
UDI-PublicM684PRTL00231
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060358
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 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPRTL0023
Device Catalogue NumberPRTL0023
Device Lot Number1757179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/29/2024
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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