MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE CD 10 MM; PROSTHESIS, KNEE

Catalog Number	00596402210
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the product was opened a foreign object (hair-like thread) was seen inside the packaging.The photo was taken with the product on a black background to make the foreign object visible.When the person in charge retrieves the product, the foreign object is removed (lost) and only the implant was retained.
Additional Manufacturer Narrative
(b)(4).G2: s korea.The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
The following sections were updated/corrected updated: visual evaluation of returned product was not able to find the described hair like thread, as the complaint states that it was thrown away.The provided photographs shows the hair like thread.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history found no additional related issues for the reported product.Medical records were not provided.This complaint cannot be confirmed as the source of the debris cannot be confirmed.A definitive root cause or condition of the device when it left zimmer biomet cannot be determined, as the product was returned opened.No actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.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
No further event information available at the time of this report.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE CD 10 MM
• 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: 21356714
• Report Number: 0001822565-2025-00311
• Device Sequence Number: 15412821
• Product Code: JWH
• UDI-Device Identifier: 00889024634718
• UDI-Public: (01)00889024634718(17)281003(10)64893995
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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
• Device Catalogue Number: 00596402210
• Device Lot Number: 64893995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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: Female