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

Model Number 133-2243

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

Patient Problem Arthralgia (2355)

Event Date 06/13/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 319186375
• Report Number: 1722511-2023-00019
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00822409015122
• UDI-Public: (01)00822409015122(17)271104(10)A244839
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 133-2243
• Device Lot Number: A244839
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2023
• Initial Date FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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: 50 YR
• Patient Sex: Female