MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING; EXTREMITY IMPLANT

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products - medical product: catalog #: 00840009400, articulation kit size 4 1 axle pin, 1 humeral bearing, lot # 65251839, and catalog #: 00840004410, humeral component plasma sprayed size 4 100 mm length for cemented, lot # 65106472.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03411, and 0001822565-2023-00484.Device evaluated by mfr: product location unknown.
Event or Problem Description
It was reported that the assembly of humeral polyethylene has a lot of resistance.The scrub nurse and surgeon had a hard time getting the pin through inserter mechanism.When the polyethylene wasn¿t seated down all the way, the surgeon proceeded to impact the polyethylene down.Due to time constraint, the surgeon changed to a different product.The polyethylene was passed off to the back table and it was able to be seated, but still had resistance getting pin through.Locking pin still wouldn¿t advance after.It was further reported that the sales rep was able to get both polyethylene's to sit after the doctor could not.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual examination of the provided photo identified the post of the bearing is not seated in the humeral stem.However, as the product was not returned, further analysis could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING
• Common Device Name: EXTREMITY IMPLANT
• 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: 16434952
• Report Number: 0001822565-2023-00482
• Device Sequence Number: 16943732
• Product Code: JDC
• UDI-Device Identifier: 00889024271456
• UDI-Public: (01)00889024271456(17)270309(10)65251839
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00840009400
• Device Lot Number: 65310130
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 73 YR
• Patient Sex: Unknown