MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH FOR CEMENTED USE ONLY; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a clinical study, that the patient underwent an initial right total elbow arthroplasty.Subsequently, the patient was evaluated due to persistent pain and limited range of motion.Radiographic imaging demonstrates humeral component loosening.The patient is indicated to undergo a future revision; however, no revision procedure has been reported to date.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The product will not be evaluated by zimmer biomet as it remains implanted in the patient.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, 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 identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed with x-rays and medical records.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.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d9, g1, g3, g6, h2, h3, h6, h11.Visual examination of the returned product identified the humeral component was returned with the poly bearing still attached and has bone cement and bio-debris.There is also some wear on the proximal end of the humeral.Damage shown around the distal end where the item/lot are located are from technician removing bone cement to get to the item/lot information.Measured the product identifiers on the print and all were conforming to the specifications of the print.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 confirmed with medical records.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: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM 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: 20774074
• Report Number: 0001822565-2024-03705
• Device Sequence Number: 19908753
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: (01)00889024271340(17)321115(10)65310121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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 Model Number: N/A
• Device Catalogue Number: 00840004410
• Device Lot Number: 65310121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 05/20/2025
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/16/2024; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Race: White