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

Model Number	101-0305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthritis (1723)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with right hip osteoarthritis received total hip arthroplasty on (b)(6) 2020.A post operative x-ray confirmed a distal stem perforation of the diaphyseal.When the wound was reopened, the surgeon also discovered a secondary fracture.Adjustments were made and wiring was applied under the perforation and the lesser trochanter.

• Brand Name: OVATION TRIBUTE
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• MDR Report Key: 10321408
• Report Number: 1722511-2020-00017
• Device Sequence Number: 14390077
• Product Code: LPH
• UDI-Device Identifier: 00822409010981
• UDI-Public: (01)00822409010981(17)240903(10)A223088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2024
• Device Model Number: 101-0305
• Device Lot Number: A223088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR