MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; BIPOLAR ACETABULAR CUP

Model Number	133-2251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient received a bipolar acetabular cup during total hip arthroplasty.On (b)(6) 2025, a dislocation of the bipolar head was observed.A closed reduction was attempted which resulted in the disassociation of the femoral head from the bipolar head.A revision was performed to replace the outer cup and femoral head with +3mm longer head.A post-op examination revealed an indentation in the liner.The surgeon commented that the dislocation was caused by the short neck length of the head.

• Brand Name: PIVOT
• Common Device Name: BIPOLAR ACETABULAR 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: 22190582
• Report Number: 1722511-2025-00009
• Device Sequence Number: 15780676
• Product Code: KWY
• UDI-Device Identifier: 00822409015207
• UDI-Public: (01)00822409015207(17)310909(10)A403581
• 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: 2025
• 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): 06/02/2025

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: 133-2251
• Device Lot Number: A403581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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