MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MILLER; DISPENSER, CEMENT

Catalog Number	00506905200
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign ¿ japan.The 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 at the distributorship, a foreign substance was found in the packaging and found non-conforming.There was no patient involvement.No further information has been provided.
Event or Problem Description
There is no further information at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h4; h6; h10.The following sections were corrected: d4 expiry date.-review of the provided photos identified foreign debris in the sterile packaging.Visual examination of the returned product found 2 sealed blisters that contains foreign debris that exceeds the acceptable limits of zpc 8.400.-review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.-reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.-the root cause of the reported event can be attributed to a manufacturing issue.-complaint is confirmed.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: MILLER
• Common Device Name: DISPENSER, CEMENT
• 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: 23358195
• Report Number: 0001822565-2025-03813
• Device Sequence Number: 8872070
• Product Code: KIH
• UDI-Device Identifier: 00889024376670
• UDI-Public: (01)00889024376670(17)290425(10)66693473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: Other
• Device Catalogue Number: 00506905200
• Device Lot Number: 66693473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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
• Patient Sex: Unknown