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

Model Number	32-8105-35-06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Extra small long right 4.5 inch length cemented interchangeable ulnar assembly cat: 32810509302 lot: 64631914.Pin/bushing replacement kit small/regular cat: 32810502501 lot: 64623044.Foreign: france.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01494.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product remains implanted.
Event or Problem Description
It was reported that the patient is being considered for a revision approximately two years post implantation due to bone fracture.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 was revised approximately two years post operation due to bone fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Proposed g-code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right elbow demonstrate a total elbow arthroplasty with bony fragmentation involving the elbow.Distal humeral resection and proximal radial resection.Radial head resection.Significant ulnar loosening with likely fracture involving the proximal ulna.Radiolucency is seen along the distal humeral component suggesting loosening of the humeral component as well.Diffuse soft tissue swelling is present.Significant surrounding soft tissue stranding could indicate evidence of trauma.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The reported event is confirmed per the mmi report.A summary of the investigation has been sent to the complainant.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
No further event information available at the time of this report.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY
• Common Device Name: ELBOW, PROSTHESIS
• 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: 17065677
• Report Number: 0001822565-2023-01492
• Device Sequence Number: 17613843
• Product Code: JDC
• UDI-Device Identifier: 00889024274044
• UDI-Public: (01)00889024274044(17)251021(10)64428942
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2025
• Device Model Number: 32-8105-35-06
• Device Catalogue Number: 32810503506
• Device Lot Number: 64428942
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 06/05/2023; 08/01/2023; 11/21/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/06/2023; 08/29/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 80 KG