MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN MC VE ASF L 11MM 8-11/GH; PROSTHESIS, KNEE

Catalog Number	42512100911
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- canada.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that an articular surface would not assemble with the tibial tray.Another articular surface was used with no issue.There is no additional information available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is not confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch 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: PSN MC VE ASF L 11MM 8-11/GH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21571974
• Report Number: 3007963827-2025-00081
• Device Sequence Number: 18210875
• Product Code: MBH
• UDI-Device Identifier: 00889024469389
• UDI-Public: (01)00889024469389(17)290102(10)66514915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150090
• 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): 06/05/2025

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: 42512100911
• Device Lot Number: 66514915
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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