MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; HEMIARTHROPLASTY PROSTHESIS

Model Number 133-2242

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

Patient Problem Arthralgia (2355)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Explant date - the report indicated a revision was planned but it had not yet occurred at the time of the report and no further information has yet been provided.

Event Description

A hemiarthroplasty was performed on (b)(6) 2018.Dislocation on 2-mar-2021 caused pain.Due to age and being bedridden, the surgeon plans to revise to reconstruct or remove the stem but will not perform total hip arthroplasty.This report is being submitted because a proposed intervention was mentioned even though it had not yet occurred.No further information has been provided by the hospital.

• 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: 14418079
• MDR Text Key: 291852773
• Report Number: 1722511-2022-00004
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00822409015115
• UDI-Public: (01)00822409015115(17)250608(10)A194935
• 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: 04/19/2022

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: 133-2242
• Device Lot Number: A194935
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 87 YR