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

Model Number	00-8400-044-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a total elbow arthroplasty and was subsequently revised due to humeral component loosening.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ulnar component plasma sprayed size 5 75 mm length right for cemented use only, cat: 00840002507, lot: 63694974.Articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product do not resterilize, cat: 00840009400, lot: 63566254.Humeral screw kit 2 humeral screws, cat: 00840009000, lot: 63653060.Report source: foreign: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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.The following sections were updated: b4, b5, g3, g7, h1, h2, h3, h6, h10 h6: proposed component 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.Root cause was unable to be determined.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.

• Brand Name: HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH
• 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: 15197780
• Report Number: 0001822565-2022-02319
• Device Sequence Number: 2239568
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: (01)00889024271340(17)270531(10)63653060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 09/28/2022

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: 00-8400-044-10
• Device Catalogue Number: 00840004410
• Device Lot Number: 63653060
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2017
• 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: 92 KG