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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO DEVELOPMENT ENTRADA; HIP STEM

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ORTHO DEVELOPMENT ENTRADA; HIP STEM Back to Search Results
Model Number 510-0214
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arthralgia (2355)
Event Date 01/30/2024
Event Type  Injury  
Event Description
During surgery, an x-ray showed the stem perforating the patient's femur and a crack occurred.The stem was removed, the broaching was redone, and the fracture was wired.The patient's fragile bone quality was referenced as a contributing factor.
 
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Brand Name
ENTRADA
Type of Device
HIP STEM
Manufacturer (Section D)
ORTHO DEVELOPMENT
12187 s. business park drive
draper UT 84020
Manufacturer (Section G)
ORTHO DEVELOPMENT
12187 s. business park drive
draper UT 84020
Manufacturer Contact
drew weaver
12187 s. business park drive
draper, UT 84020
8015539991
MDR Report Key18832220
MDR Text Key336850990
Report Number1722511-2024-00004
Device Sequence Number1
Product Code MEH
UDI-Device Identifier00822409035991
UDI-Public(01)00822409035991(17)280314(10)A284087
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/28/2024
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 Number510-0214
Device Lot NumberA284087
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/28/2024
Initial Date FDA Received03/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexFemale
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