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

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	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in australia.H6: proposed component code: mechanical (g04) - femur.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a femoral component was not used due to damaged packaging and questioned sterility.Upon opening the outer box during setup for implantation on an unknown date, the packaging was noted to be heavily deformed and warped.Although the seals appeared intact, the surgical team questioned the sterility of the device and decided not to use it.The device was not implanted.No known impact or consequence to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, h2, h6.The reported event was able to be confirmed via product return.Visual examination of the returned product found the sterile packaging exhibited thermal damage.The inner blister seal was measured and found to be narrow, however, there is sufficient adhesive residue on the blister flange, which indicates the seal was conforming.Sterility is considered not breached.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information to report.

• Brand Name: PSN FEM CR POR CCR STD SZ 11 R
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL
• 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: 23556363
• Report Number: 0001822565-2025-04129
• Device Sequence Number: 9829521
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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?: Yes
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/26/2026
• 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