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

Model Number	101-0309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No radiographs were provided.Part met acceptance criteria upon release.There is no evidence of implant or instrumentation malfunction.The instructions for use lists potential adverse effects of hip arthroplasty that include femoral bone fracture during intra-operative bone preparation or impaction, post-operative femoral or acetabular fracture by trauma, excessive loading, bone defects from previous surgery or reaming, and bone resorption.If information is obtained that was not available at the time of the initial report, a follow-up will be filed as appropriate.
Event or Problem Description
A (b)(6) year old patient underwent bipolar hip arthroplasty on (b)(6) 2018 due to femoral neck fracture.The operation was successful as well as the initial followup.Subsequent followup discovered a femoral bone fracture causing stem rotation.On (b)(6) 2018, the patient underwent revision surgery and the stem was replaced with another company's stem and cable around the bone.The surgeon indicated that the patient's bone condition was the issue.

• Brand Name: OVATION TRIBUTE
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 7805627
• Report Number: 1722511-2018-00027
• Device Sequence Number: 1574490
• Product Code: LPH
• UDI-Device Identifier: 00822409011025
• UDI-Public: (01)00822409011025(17)230108(10)A188098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 01/08/2023
• Device Model Number: 101-0309
• Device Lot Number: A188098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1