MAUDE Adverse Event Report: ORTHO DEVELOPMENT OVATION; TOTAL HIIP 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	01/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
After bha, postoperative imaging confirmed a bone fracture.The patient was reopened and the bone was reinforced with a plate and cable.The surgeon speculated the fracture may have occurred when inserting the stem and reported as unfamiliarity with a series of broaching movements.

• Brand Name: OVATION
• Common Device Name: TOTAL HIIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 12724995
• Report Number: 1722511-2021-00014
• Device Sequence Number: 3855992
• Product Code: LPH
• UDI-Device Identifier: 00822409010868
• UDI-Public: (01)00822409010868(17)240731(10)A220635
• 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): 10/06/2021

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: 07/31/2024
• Device Model Number: 101-0007
• Device Lot Number: A220635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR