MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEM CONST LNR 56 X 32; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported during unpacking of the loan set for this case, it was noted that the outer plastic wrapping on the tray was missing and the box felt unusually light.The packaging appeared to have been previously opened.Upon inspection, the implant was found to be completely unsterile, with no sterile packaging present.The issue was identified prior to use.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4 lot number.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4 (expiration date, udi #), g3, g6, h2, h3, h4, h6, h11 the reported event could not be confirmed.No product was returned or pictures provided, therefore visual evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: CEM CONST LNR 56 X 32
• Common Device Name: PROSTHESIS, HIPS
• 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: 23802245
• Report Number: 0001822565-2025-04495
• Device Sequence Number: 9389849
• Product Code: KWZ
• UDI-Device Identifier: 00889024670129
• UDI-Public: (01)00889024670129(17)300729(10)67183865
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/14/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00711505632
• Device Lot Number: 67183865
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 03/27/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/20/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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