MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; HEMIARTHROPLASTY PROSTHESIS

Model Number 133-2251

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthralgia (2355)

Event Date 10/18/2022

Event Type  Injury  

Event Description

The patient received bipolar hip arthroplasty on (b)(6) 2022.Dislocation occurred and caused pain.An x-ray confirmed that the head was dislocated from the cup and the cup was dislocated from the acetabulum.On (b)(6) 2022, a revision was performed to replace the components.

• Brand Name: PIVOT
• Type of Device: HEMIARTHROPLASTY 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: 15960774
• MDR Text Key: 305281185
• Report Number: 1722511-2022-00009
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00822409015207
• UDI-Public: (01)00822409015207(17)250626(10)A196916
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 133-2251
• Device Lot Number: A196916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male