MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B; PROSTHESIS, ELBOW

Catalog Number	00840009400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat: 00840001407 lot: 64590931 ulnar component plasma sprayed size 4 75 mm length left for cemented use only.Cat: 00840004415 lot: 64916243 humeral component plasma sprayed size 4 150 mm length for cemented use only.Cat: 00840009000 lot: 65471795 humeral screw kit 2 humeral screws.G2: foreign-australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 -02210, 0001822565 - 2023 -02211.
Event or Problem Description
It was reported that the patient underwent revision of the left elbow due to loosening of the ulna component and loss of flexion or extension.No additional patient consequences were reported.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B
• Common Device Name: PROSTHESIS, ELBOW
• 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: 17596396
• Report Number: 0001822565-2023-02212
• Device Sequence Number: 7421579
• Product Code: JDC
• UDI-Device Identifier: 00889024271456
• UDI-Public: (01)00889024271456(17)261114(10)65064304
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 12/19/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00840009400
• Device Lot Number: 65064304
• 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: 08/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 12/20/2023
• Date Device Manufactured: 12/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male