MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; BIPOLAR CUP

Model Number	133-2244
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 a patient received a bipolar hip replacement.On an unknown date, the patient dislocated.On (b)(6) 2025, a revision surgery was performed and the components were replaced.The surgeon suggested that the reason for the dislocation was possible congenital acetabular dysplasia.

• 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 ; 8015539991
• MDR Report Key: 23992188
• Report Number: 1722511-2026-00001
• Device Sequence Number: 10536296
• Product Code: KWY
• UDI-Device Identifier: 00822409015139
• UDI-Public: (01)00822409015139(17)301130(10)A297393
• 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: 2024
• Device Explanted Year: 2024
• 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): 01/07/2026

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: 133-2244
• Device Lot Number: A297393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: 82 YR
• Patient Sex: Female