MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN ASF CR 10MM VE R 3-11 EF; PROSTHESIS, KNEE

Catalog Number	42-5220-005-10
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown tibial plate, #item unknown, #lot unknown.Therapy date: (b)(6) 2025 g2: foreign - event occurred in japan.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that despite multiple attempts to insert the articular surface implant while carefully noting the insertion direction, it would not seat.Upon checking the shape of the surface, it appeared that it had become deformed.Therefore, a new implant of the same size was opened and used instead.There was no patient injury as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,d9,g1,g3,g6,h1,h2,h3,h6.The cmp was confirmed.Visual inspection of the returned device shows signs of use (dings around the extraction slot) there are indents on the anterior surface.The dovetail feature is both flared and compressed.There are gouges on the posterior end of the dovetail feature on the lateral side review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar for the reported item and no additional complaints for part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in persona® the personalized knee®.The root cause is attributed to a failure to follow instructions.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.

• Brand Name: PSN ASF CR 10MM VE R 3-11 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23693389
• Report Number: 3007963827-2025-00480
• Device Sequence Number: 9152849
• Product Code: MBH
• UDI-Device Identifier: 00889024241626
• UDI-Public: (01)00889024241626(17)300213(10)67152186
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 42-5220-005-10
• Device Lot Number: 67152186
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown