MAUDE Adverse Event Report: ORTHO DEVELOPMENT OVATION TRIBUTE; TOTAL HIP PROSTHESIS

Model Number 101-1305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 05/08/2019

Event Type  Injury  

Event Description

Original hip surgery was performed on (b)(6) 2019.A peri-stem fracture occurred after surgery.On (b)(6) 2019, the surgeon re-operated and replaced the wiring.

• 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 Key: 10158734
• MDR Text Key: 195276076
• Report Number: 1722511-2020-00009
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00822409011261
• UDI-Public: (01)00822409011261(17)230727(10)A198975
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/27/2020

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 Date: 07/27/2023
• Device Model Number: 101-1305
• Device Lot Number: A198975
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR