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

Model Number	700-0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During total hip arthroplasty, a bone fracture was observed at the transverse condyle that was reinforced with cement and two screws.

• Brand Name: ALPINE
• Common Device Name: TOTAL HIP ARTHROPLASTY 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: 16880322
• Report Number: 1722511-2023-00013
• Device Sequence Number: 12627804
• Product Code: KWY
• UDI-Device Identifier: 00822409000067
• UDI-Public: (01)00822409000067(17)270802(10)A272613
• 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: 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): 04/13/2023

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: 700-0014
• Device Lot Number: A272613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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 Sex: Female