MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ASF CPS 14MM VE L 6-9 CD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS

Catalog Number	42512600514
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the articular surface was inserted manually, it went in without resistance and was almost fully seated against the tibial plate.Surgeon used the surface inserter to perform the final push; however, the surgeon did not feel a sensation that the surface was engaging with the tibia.When he used the elevator to push up on the surface from the recess at the front of the tibia plate, the surface came up easily.As a result, the surgery was completed with another articular surface.There was a 10 minute surgical delay.The patient had no consequences or impact.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42542006701 - tibia fixed cemented left size d stem extension use required - 67301201.G2: foreign country: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: PERSONA ASF CPS 14MM VE L 6-9 CD
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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: 25470415
• Report Number: 3007963827-2026-00249
• Device Sequence Number: 10307563
• Product Code: MBH
• UDI-Device Identifier: 00889024237957
• UDI-Public: (01)00889024237957(17)270719(10)65557943
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/11/2026

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: 42512600514
• Device Lot Number: 65557943
• 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: 05/26/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Female