MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY SMALL 8 INCH LENGTH FOR CEMENTED USE ONLY; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It has been reported that the patient had an initial left total elbow arthroplasty on an unknown date with unknown implants.The patient was revised.During the revision it was noted that the ulnar component was loose.Subsequently, the patient was revised for a second time due to unknown reasons.Due diligence complete.No further information has been provided.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is unable to be confirmed.H6 component code: proposed code: mechanical (g04)- stem.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information is available regarding the incident.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY SMALL 8 INCH LENGTH FOR CEMENTED USE ONLY
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 20439406
• Report Number: 0001822565-2024-03248
• Device Sequence Number: 7995126
• Product Code: JDC
• UDI-Device Identifier: 00889024273955
• UDI-Public: (01)00889024273955(17)251027(10)64856372
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 10/27/2025
• Device Model Number: N/A
• Device Catalogue Number: 32810502508
• Device Lot Number: 64856372
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male