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	01/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During hip arthroplasty, a femoral bone fracture occurred when inserting the hip stem.Cable was used to reinforce the bone.The surgeon stated that the event was not related to this device.

• 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: 12197106
• Report Number: 1722511-2021-00007
• Device Sequence Number: 19202656
• Product Code: LPH
• UDI-Device Identifier: 00822409010868
• UDI-Public: (01)00822409010868(17)250508(10)A236376
• 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: 2021
• 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): 06/22/2021

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: 05/08/2025
• Device Model Number: 101-0007
• Device Lot Number: A236376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR