MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH; PROSTHESIS, KNEE

Catalog Number	42557000114
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when two stems were opened, the plastic packaging on the sterile top piece appeared to have adhesive residue adhered to the plastic.The malfunction were the same with both devices' packaging.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42557000114; stem extension tapered cemented 14 mm diameter +30 mm length; 67197454.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: updated: a1; a3; b4; b5; d2; g1; g3; g6; h1; h2; the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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; g1; g3; g6; h1; h2; h3; h6; h10.Section h4 was corrected.Complaint can be confirmed.Visual evaluation of the returned product found white residue on the retainer lid that is visually consistent with glue transferred from the tyvek lid during the sealing operation due to a small clearance between the tyvek lid and the retainer.The adhesive residue is considered acceptable as it does not contact the implant, which is contained in a poly bag.Upon receiving additional information and reassessing the reported event, it was determined that this not constitute any malfunction as it is acceptable and does not contribute to any adverse event.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as the packaging design due to the small clearance between the tyvek lid and retainer.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: STEM EXTENSION TAPERED CEMENTED 14 MM DIAMETER +30 MM LENGTH
• 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: 22805765
• Report Number: 0001822565-2025-02935
• Device Sequence Number: 8846508
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)350525(10)67273028
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2025

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: 42557000114
• Device Lot Number: 67273028
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 12/04/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/02/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 0001822565-2025-02933
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Female