MAUDE Adverse Event Report: ORTHO DEVELOPMENT LEGEND; HIP PROSTHESIS

Model Number	170-0446
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During hip arthroplasty, the acetabulum was perforated during cup impaction.Bone was grafted into the perforated area and the surgery was completed without any problems.Strong bone fragility was noted as a factor by the surgeon.

• Brand Name: LEGEND
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 17337912
• Report Number: 1722511-2023-00018
• Device Sequence Number: 7614213
• Product Code: LPH
• UDI-Device Identifier: 00822409035267
• UDI-Public: (01)00822409035267(17)270608(10)A270430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2023

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 Model Number: 170-0446
• Device Lot Number: A270430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female