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

Model Number	101-0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During total hip arthroplasty, intraoperative fractures occurred in the greater and lesser trochanter when inserting the stem.The surgeon reinforced the fractures with cable.The surgeon commented that the patient's fragile bone quality was the cause.

• Brand Name: OVATION
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 10738120
• Report Number: 1722511-2020-00028
• Device Sequence Number: 17014959
• Product Code: LPH
• UDI-Device Identifier: 00822409010868
• UDI-Public: (01)00822409010868(17)240927(10)A224603
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 09/27/2024
• Device Model Number: 101-0007
• Device Lot Number: A224603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR