MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT BIPOLAR; TOTAL HIP PROSTHESIS

Model Number	133-2243
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient received a bipolar acetabular cup during hip arthroplasty.On (b)(6) 2023, a dislocation was reported.On (b)(6) 2023, a revision was performed to replace the outer cup and femoral head.A post-op examination revealed an indentation in the liner.The surgeon suggested the dislocation was caused by patient movement.

• Brand Name: PIVOT BIPOLAR
• Common Device Name: TOTAL HIP PROSTHESIS
• 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: 17339273
• Report Number: 1722511-2023-00019
• Device Sequence Number: 6534044
• Product Code: KWY
• UDI-Device Identifier: 00822409015122
• UDI-Public: (01)00822409015122(17)271104(10)A244839
• 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: 2023
• Device Explanted Year: 2023
• 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): 07/02/2023

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: 133-2243
• Device Lot Number: A244839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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: 50 YR
• Patient Sex: Female