MAUDE Adverse Event Report: Ortho Development Pivot; Bipolar Cup

Model Number	133-2245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury

• Brand Name: Pivot
• Common Device Name: Bipolar Cup
• 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 ; +1(801)553-9991
• MDR Report Key: 50509969
• Report Number: 1722511-2026-00021
• Device Sequence Number: 15780184
• Product Code: KWY
• UDI-Device Identifier: 00822409015146
• UDI-Public: (01)00822409015146(17)321104(10)A423669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 133-2245
• Device Lot Number: A423669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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