MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEM CR POR CCR STD SZ 11 R; PROSTHESIS, KNEE

Catalog Number	42502807002
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.H6: proposed component code: mechanical (g04) - femur.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the implant packaging appeared to be melted prior to use.The device was not used and a secondary implant was retrieved to complete the procedure.There was no patient impact and no adverse events have been reported as a result of the malfunction.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; h2; h3; h6; h11.Visual evaluation of the returned product found the sterile packaging exhibits damage that is visually consistent with thermal damage.Evaluation of the returned product found the inner blister seal was narrow.Review confirmed the narrow seal can be attributed to cavity deformation, such as warping or melting.This condition may lead to changes in the cavity dimensions, which in turn can cause the adhesive to shrink and give the appearance of a compromised seal.Sterility is considered not breached.Reported event has been confirmed by review of the returned product.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 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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: PERSONA FEM CR POR CCR STD SZ 11 R
• 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: 23639407
• Report Number: 0001822565-2025-04286
• Device Sequence Number: 9258658
• Product Code: MBH
• UDI-Device Identifier: 00889024230842
• UDI-Public: (01)00889024230842(17)350225(10)67001203
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• 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): 05/08/2026

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: 42502807002
• Device Lot Number: 67001203
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown