MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SSK 360 R FEM 75MM; PROSTHESIS, KNEE

Catalog Number	185268
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an implant was found to have damaged packaging prior to implantation.The inner vacuum packaging appeared to be intact and the device was implanted.There was been no reported patient impact or adverse events as a result of the packaging malfunction.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in germany.Visual examination of the provided pictures identified damaged sterile packaging.The sterile blister is cracked and foam is abraded.Sterility has been compromised.Reported event was confirmed by review of provided photographs.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event can be attributed to transit damage.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: VANGUARD SSK 360 R FEM 75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25019459
• Report Number: 0001825034-2026-01131
• Device Sequence Number: 13345431
• Product Code: JWH
• UDI-Device Identifier: 00880304481978
• UDI-Public: (01)00880304481978(17)260428(10)3782941
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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 Expiration Date: 04/28/2026
• Device Catalogue Number: 185268
• Device Lot Number: 3782941
• 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: 04/14/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2016
• 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