MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LEFT SIZE G CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00599401791
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in france.The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the cardboard packaging was damaged and upon opening, there was a hole in the first blister.The second blister also had two notches.The implant was unusable because the packaging was severely damaged.The patient remained under anesthesia for another 2 hours while an implant was retrieved from another facility.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h11.No product was returned; visual evaluation of the provided photos found the outer carton exhibits crush damage.Additionally, both of the sterile barriers have been cracked.Sterility has been breached.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event (damaged packaging) can be attributed to transit damage.The root cause of the reported event (receipt of damaged goods in loaner kit) can be attributed to a distribution issue.The complaint was confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN LEFT SIZE G CEMENTED OPTION FEMORAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• 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: 22284578
• Report Number: 0001822565-2025-02000
• Device Sequence Number: 8892831
• Product Code: JWH
• UDI-Device Identifier: 00889024224841
• UDI-Public: (01)00889024224841(17)310105(10)64895259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• 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
• Report Date (Section B): 09/26/2025

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: 00599401791
• Device Lot Number: 64895259
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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: Male