MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 3; PROSTHESIS, KNEE

Catalog Number	00598003701
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	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total knee arthroplasty, a hair was found in the packaging of the tibial tray upon opening the device.Another implant was obtained and the surgery was completed successfully.There was no surgical delay or patient impact and no adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h11.Visual evaluation of the returned product found a hair-like fiber was found in the sterile packaging (blister seal).Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event is attributed to the packaging operator not following the work instructions provided.The condition of the device when it left zimmer biomet is considered non-conforming to specification.Complaint sample was evaluated and the reported event 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 at time of this report.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 3
• 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: 19248354
• Report Number: 0001822565-2024-01473
• Device Sequence Number: 6590437
• Product Code: JWH
• UDI-Device Identifier: 00889024217577
• UDI-Public: (01)00889024217577(17)331023(10)J7643569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 00598003701
• Device Lot Number: J7643569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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: Prefer Not To Disclose