MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN ALL-POLY PATELLA; PROSTHESIS KNEE

Catalog Number	00597206526
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: singapore.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that deformation was observed in the packaging of both inner and outer.Another device was used to complete the surgery.No more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d5; d9; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual evaluation of the returned product found the sterile packaging exhibits damage that is visually consistent with thermal damage.Additional evaluation found a void in the outer blister seal.Sterility is considered breached.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.The root cause of the reported event (warped blisters) can be attributed to transit damage.The cause of thermal damage in the apac region is occurring in transit and storage conditions from the time a package leaves the manufacturing site to the time it arrives in the distribution center.However, the root cause of the reported event (defective seal) can be attributed to a manufacturing issue.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: NEXGEN ALL-POLY PATELLA
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21969491
• Report Number: 0002648920-2025-00127
• Device Sequence Number: 20936251
• Product Code: JWH
• UDI-Device Identifier: 00889024635364
• UDI-Public: (01)00889024635364(17)290610(10)66769392
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 09/25/2025

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: 00597206526
• Device Lot Number: 66769392
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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