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

Model Number	700-0013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
An intraoperative femoral bone fracture occurred during hip replacement surgery when the stem was inserted.The surgeon used cable to fix the fracture then performed an operational test that confirmed the fracture did not open.

• Brand Name: ALPINE
• Common Device Name: TOTAL HIP PROSTHESIS
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 10547970
• Report Number: 1722511-2020-00020
• Device Sequence Number: 3074138
• Product Code: KWL
• UDI-Device Identifier: 00822409000050
• UDI-Public: (01)00822409000050(17)230921(10)A202123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141001
• 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): 09/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 700-0013
• Device Lot Number: A202123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1