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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO DEVELOPMENT OVATION TRIBUTE; TOTAL HIP PROSTHESIS
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ORTHO DEVELOPMENT OVATION TRIBUTE; TOTAL HIP PROSTHESIS Back to Search Results
Model Number 101-0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hip Fracture (2349)
Event Date 06/26/2019
Event Type  Injury  
Event Description
Original hip surgery was performed on (b)(6) 2019.After surgery, the patient slipped and reported pain since then.On (b)(6) 2019, the surgeon re-operated and placed wiring due to a peri-stem fracture.
 
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Brand Name
OVATION TRIBUTE
Type of Device
TOTAL HIP PROSTHESIS
Manufacturer (Section D)
ORTHO DEVELOPMENT
12187 s. business park drive
draper, ut
Manufacturer (Section G)
ORTHO DEVELOPMENT
12187 s. business park drive
draper, ut
Manufacturer Contact
drew weaver
12187 s. business park drive
draper, ut 
5539991
MDR Report Key10158640
MDR Text Key195275624
Report Number1722511-2020-00008
Device Sequence Number1
Product Code LPH
UDI-Device Identifier00822409010943
UDI-Public(01)00822409010943(17)240225(10)A210768
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/26/2020
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 Expiration Date02/25/2024
Device Model Number101-0301
Device Lot NumberA210768
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/26/2020
Initial Date FDA Received06/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2019
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 Age71 YR
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