MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN ASF PS 14MM VE R 6-9 CD; PROSTHESIS, KNEE

Catalog Number	42522400514
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- japan 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.
Event or Problem Description
It was reported that an articular surface didn¿t mate with tibial plate.The surgeon carefully tried to insert it, after that, it was discovered that the back side of the articular surface was deformed.The surgery was completed with another articular surface.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, d9, g1, g2, g3, g6, h1, h2, h3, h6, and h11 visual examination of the returned product shows that it exhibits signs of use (dings and scratches on the bottom surface as well as in and around the extraction slot).The dovetail feature shows signs of damage (both compressed and flared) as well as numerous dings.Medical records were not provided.Review of the device history record identified no deviations or anomalies during manufacturing.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.The root cause is attributed to a failure to follow instructions.This complaint is confirmed.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 further event information available at the time of this report.

• Brand Name: PSN ASF PS 14MM VE R 6-9 CD
• 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: 23586484
• Report Number: 3007963827-2025-00468
• Device Sequence Number: 13076437
• Product Code: MBH
• UDI-Device Identifier: 00889024243637
• UDI-Public: (01)00889024243637(17)280214(10)65645172
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• 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): 04/23/2026

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: 42522400514
• Device Lot Number: 65645172
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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