MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN ASF CPS 10MM VE R 6-9 EF; PROSTHESIS, KNEE

Catalog Number	42522600710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an articular surface would not assemble with the tibial tray during surgery.When implanting the insert, it did not fit in the tibia, and it created a posterior slot on the underside of the polyethylene.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4).D10- medical product: psn asf cps 12mm ve r 6-9 ef, item# 42522600712, lot# 66691467.G2- spain.H3- customer has indicated that the product will 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.

• Brand Name: PSN ASF CPS 10MM VE R 6-9 EF
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23681706
• Report Number: 3007963827-2025-00477
• Device Sequence Number: 9984302
• Product Code: MBH
• UDI-Device Identifier: 00889024244573
• UDI-Public: (01)00889024244573(17)300806(10)67457792
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K123459
• 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): 05/05/2026

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: 42522600710
• Device Lot Number: 67457792
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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