MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; BIPOLAR CUP

Model Number	133-2853
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient with a bipolar hip construct fell causing a dislocation of the bipolar cup from the femoral head.The patient is infected and this is the second time the patient has had a bipolar cup disassociate from a femoral head.On (b)(6) 2025, the patient was revised to correct the issue.

• 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: 23452247
• Report Number: 1722511-2025-00022
• Device Sequence Number: 15713553
• Product Code: KWY
• UDI-Device Identifier: 00822409015375
• UDI-Public: (01)00822409015375(17)320606(10)A415594
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2025

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: 133-2853
• Device Lot Number: A415594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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 Age: 85 YR
• Patient Sex: Male