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

Model Number	101-0308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a patient received an artificial hip joint with a stem and bipolar cup.On (b)(6) 2023, stem subsidence was observed.On (b)(6) 2023, inner head prolapse was observed.On (b)(6) 2023, a revision was performed to replace the stem, the outer cup, and inner head.The surgeon stated that stem subsidence was due to internal placement and small size.The subsidence led to dislocation.

• Brand Name: OVATION TRIBUTE
• Common Device Name: TOTAL HIP ARTHROPLASTY PROSTHESIS
• 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 Key: 17039813
• Report Number: 1722511-2023-00015
• Device Sequence Number: 6515522
• Product Code: LPH
• UDI-Device Identifier: 00822409011018
• UDI-Public: (01)00822409011018(17)260713(10)A255464
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 07/13/2026
• Device Model Number: 101-0308
• Device Lot Number: A255464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male