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

Model Number	133-2246
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, a patient received a bipolar acetabular cup.On (b)(6) 2024, the patient fell and dislocated the bipolar head.On (b)(6) 2024, the patient was revised and the device replaced.

• 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: 20599509
• Report Number: 1722511-2024-00015
• Device Sequence Number: 8787443
• Product Code: KWY
• UDI-Device Identifier: 00822409015153
• UDI-Public: (01)00822409015153(17)261011(10)A225154
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2024

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: 133-2246
• Device Lot Number: A225154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2019
• 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: 72 YR
• Patient Sex: Male