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

Model Number	N/A
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 42-5006-054-02, psn fem ps cmt ccr std sz 3 r, lot: 63304725.42-5320-064-02, psn tib stm 5 deg sz c r, lot: 67272286.00-5901-035-27, 3.5mm hex headed scr x27mm 2pk lot:67143096.00-5901-020-00, hdless trc drill pin 75mm bx4 lot: 67207620.42-5226-004-14, psn asf cps 14mm ve r 3-5 cd, lot: 66772220.42-5570-001-14, psn tpr st 14 x +30 mm, lot: 67317014.42-5402-000-29, all poly pat ve 29 mm dia, lot: 67072314.110035368, biomet bc r 1x40 us lot: av44ck0115.110035368, biomet bc r 1x40 us lot: au04ba0207.32-700036, thrd pin hdls.125d st 2pk lot:095860.98-0002-415-21 psn cm fm/cm tb/cps/ve psn pt, lot: unknown.42-5570-001-14 psn straight hyb st 14 x+30 m lot: 67197368.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 there was a white substance on inner package on the implant that was opened during surgery.All available information has been provided.
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 provided photo 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.

• 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: 22988111
• Report Number: 0001822565-2025-03293
• Device Sequence Number: 18528990
• Product Code: JWH
• UDI-Device Identifier: 00889024247734
• UDI-Public: (01)00889024247734(17)350409(10)67197368
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133737
• 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
• Report Date (Section B): 12/30/2025

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 Model Number: N/A
• Device Catalogue Number: 42557000114
• Device Lot Number: 67197368
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 09/06/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 72 YR
• Patient Sex: Female