MAUDE Adverse Event Report: ORTHO DEVELOPMENT PIVOT; HEMIARTHROPLASTY PROSTHESIS

Model Number	133-2242
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1722511-2022-00004
• Device Sequence Number: 17511361
• Product Code: KWY
• UDI-Device Identifier: 00822409015115
• UDI-Public: (01)00822409015115(17)250608(10)A194935
• 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: 2018
• 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): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2025
• Device Model Number: 133-2242
• Device Lot Number: A194935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Unknown