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.
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.
Event or Problem Description
There is no further information at the time of this report.

• 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: 23358193
• Report Number: 0001822565-2025-03812
• Device Sequence Number: 8872069
• 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