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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR PRESERVE HIP STEM; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. PROFEMUR PRESERVE HIP STEM; HIP COMPONENT Back to Search Results
Model Number PPRXXXXX
Device Problem Loss of Osseointegration (2408)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
As of (b)(6) 2022, there are 339 hips implantations with the profemur preserve classic hip stem in the german registry (eprd).It should be noted that due to the phasing out of profemur preserve modular hip stem, there are still 94 hips implanted with this stem within the national joint registry.The following information is provided by the registry without differentiating between classic and modular stems.There were 13 revisions reported, each will be captured separately.Reason for revision: aseptic loosening.
 
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Brand Name
PROFEMUR PRESERVE HIP STEM
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 Key18588391
MDR Text Key333852775
Report Number3010536692-2024-00049
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/26/2024
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 Other
Device Model NumberPPRXXXXX
Device Catalogue NumberPPRXXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/29/2023
Initial Date FDA Received01/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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