MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; BIPOLAR CUP

Model Number	133-2241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient received a bipolar hip replacement.Postoperatively at some point, the implant dislocated and was manually reduced.On (b)(6) 2026, an x-ray revealed that the implant had dislocated again.On (b)(6) 2026, the implants were removed without replacement implants.

• 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: 25652541
• Report Number: 1722511-2026-00015
• Device Sequence Number: 15890327
• Product Code: KWY
• UDI-Device Identifier: 00822409015108
• UDI-Public: (01)00822409015108(17)300405(10)A285393
• 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
• Device Explanted Year: 2026
• 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): 06/29/2026

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: 133-2241
• Device Lot Number: A285393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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: 83 YR
• Patient Sex: Female