MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL; PROSTHESIS, ELBOW

Catalog Number	32810502704
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 32810502701 lot: 64596821 pin/bushing replacement kit extra small for use with extra small humeral implants: 32-8105-27- 04,06.G2: foreign- australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient had an elbow revision approximately twenty seven (27) months post-initial implantation due to implant breakage.No additional patient consequences were reported.
Additional Manufacturer Narrative
Based on the review of additional information, it was determined that this medwatch report is a duplicate of 1822565 -2024 -03501.The initial report was forwarded in error and should be voided.
Event or Problem Description
Based on the review of additional information, it was determined that this medwatch report is a duplicate of 1822565 -2024 -03501.The initial report was forwarded in error and should be voided.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL
• Common Device Name: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20634387
• Report Number: 0001822565-2024-03500
• Device Sequence Number: 20699053
• Product Code: JDC
• UDI-Device Identifier: 00889024274006
• UDI-Public: (01)00889024274006(17)240229(10)64163243
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 32810502704
• Device Lot Number: 64163243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/15/2025
• Date Device Manufactured: 02/22/2019
• 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; Hospitalization
• Patient Sex: Female