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

Model Number 100-0008

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

Patient Problem Hip Fracture (2349)

Event Date 05/21/2020

Event Type  Injury  

Event Description

During a total hip surgery performed on (b)(6) 2020, the surgeon inserted the stem deeper than intended and imaging confirmed an oblique fracture.The surgeon adjusted the stem to the expected position and wired the fracture.

• 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: 10160395
• MDR Text Key: 195379104
• Report Number: 1722511-2020-00013
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00822409010639
• UDI-Public: (01)00822409010639(17)240716(10)A219326
• 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: 05/31/2020

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 Model Number: 100-0008
• Device Lot Number: A219326
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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: 82 YR