MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY SMALL; PROSTHESIS, ELBOW

Model Number	32-8105-25-06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: extra small right 3 inch length cemented interchangeable ulnar assembly: catalog#32810504302, lot#65171938.Report source: foreign: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right elbow arthroplasty.Subsequently, at a follow up appointment, it was determined that the axis pins had disassociated and were no longer locking the two components together.Approximately six weeks post-implantation the patient underwent revision surgery where the locking pins were replaced without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided photos showed the explanted pins in a plastic bag.However, as the product was not returned, further analysis could not be performed.Device history record was reviewed and no discrepancies related to the reported event 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report has been submitted to relay additional information.The following sections have been updated: radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial normal appearance of the right elbow arthroplasty with subsequent progressive disassociation of the outer and internal axis pins as noted.The reported event was confirmed through provided x-rays.Additional information provided does not alter previously reported investigation results.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: INTERCHANGEABLE HUMERAL ASSEMBLY SMALL
• 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: 15534207
• Report Number: 0001822565-2022-02851
• Device Sequence Number: 8133712
• Product Code: JDC
• UDI-Device Identifier: 00889024273948
• UDI-Public: (01)00889024273948(17)251026(10)64363396
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/05/2023

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 Expiration Date: 10/26/2025
• Device Model Number: 32-8105-25-06
• Device Catalogue Number: 32810502506
• Device Lot Number: 64363396
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 04/21/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 12/22/2022; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female