MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEE H11 NARRATIVE; PROSTHESIS, ELBOW

Catalog Number	00840009400
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D1: articulation kit size 4 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b sterile product do not resterilize.D10: cat: 00840009000, lot: 66207351 humeral screw kit 2humeral screws.Cat: 00840004415, lot: 65357091 humeral component plasma sprayed size 4 150 mm length for cemented use only.Cat: 00840002407, lot: 65850710 ulnar component plasma sprayed size 4 75 mm length right for cemented use only.G2: foreign- australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device cannot be contaminated.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 reported that the patient was revised nine months post-initial implantation due to loosening of the humerus and ulna components.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: SEE H11 NARRATIVE
• 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: 21872502
• Report Number: 0001822565-2025-01075
• Device Sequence Number: 7899111
• Product Code: JDC
• UDI-Device Identifier: 00889024271456
• UDI-Public: (01)00889024271456(17)260318(10)64895818
• 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 Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 05/06/2025

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: 03/18/2026
• Device Catalogue Number: 00840009400
• Device Lot Number: 64895818
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 04/13/2021
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female