MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 6 200 MM LENGTH LONG FLANGE; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Nodule (4551); Insufficient Information (4580)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient will have a possible elbow revision due to an unknown reason on an unknown date.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10: medical product: catalog #: unknown, unknown ulnar, lot #: unknown.Catalog #: unknown, unknown articulation kit, lot #: unknown.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.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 00840001411, ulnar component plasma sprayed size 4 115, lot # 65106492; catalog #: 00840009500, articulation kit size 5/6, lot # 66020939.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 further reported that the patient states she has had a large knot on the posterior aspect of her elbow.She says it hurts when she tries to move the elbow and has not been lifting with it at all.After further imaging, a ct scan revealed circumferential lucency around the length of the ulnar component concerning for loosening.The surgeon discussed conservative management, but the patient elected to proceed with a surgical procedure to reduce pain, improve function, and decrease the risk of periprosthetic fracture.The revision is scheduled for a future date; no further intervention has been reported to date.
Event or Problem Description
It was further reported that the patient underwent a revision procedure due to a fibrous nodule around the joint, lucency in the distal ulna, and significant forearm pain.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d4, g1, g3, g6, h2, h4, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.H6 component codes: proposed g-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.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 6 200 MM LENGTH LONG FLANGE
• Common Device Name: EXTREMITY IMPLANT
• 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: 20248705
• Report Number: 0001822565-2024-03011
• Device Sequence Number: 12585659
• Product Code: JDC
• UDI-Device Identifier: 00889024271432
• UDI-Public: (01)00889024271432(17)260630(10)63377996
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/25/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00840005620
• Device Lot Number: 63377996
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 02/28/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/18/2024; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2016
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG