MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISP MIX BOWL W SPATULA 20 PCE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	00504901100
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.Visual evaluation of the returned product found pouches with peeling in the seal area.The seals were measured and found to be non-conforming.The device history records for [00504901100, 85682882] were reviewed for deviations and/or anomalies with the following related anomalies/deviations identified: ncr00083167.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.Actions have been initiated for the reported event.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 during receiving inspection of cement bowls, there were issues with the sealing area of the packaging.The defects were identified during incoming inspection.There was no patient involvement.Attempts have been made and no further information has been provided.

• Brand Name: DISP MIX BOWL W SPATULA 20 PCE
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• 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: 24896562
• Report Number: 0001822565-2026-01309
• Device Sequence Number: 18344463
• Product Code: JDZ
• UDI-Device Identifier: 00889024376564
• UDI-Public: (01)00889024376564(17)301103(10)85682882
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: Health Professional
• Device Catalogue Number: 00504901100
• Device Lot Number: 85682882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• 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