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

Model Number 100-0002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 08/30/2019

Event Type  Injury  

Event Description

Immediately after closing the wound from hip replacement surgery, an x-ray confirmed a dislocation.The wound was reopened and the surgeon made adjustments.During reduction, a bone fracture occurred near the trochanter which the surgeon wound with cable.The surgeon reported that this was the "result of various conditions such as the soft tissue condition of the patient, the shape of the acetabulum, the bone quality, and the pit hole in the ocm approach.".

• Brand Name: OVATION
• Type of Device: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, ut ; 5539991
• MDR Report Key: 10308873
• MDR Text Key: 199989502
• Report Number: 1722511-2020-00016
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00822409010578
• UDI-Public: (01)00822409010578(17)221003(10)A183021
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: 100-0002
• Device Lot Number: A183021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 93 YR