MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522400710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the articular surface did not mate with the tibial plate.The operation was completed with a different articular surface.This resulted in a 5¿10-minute surgical delay.There was no consequences or impact to the patient.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical product - 42532007102 - tibia cemented 5 degree stemmed right size e - unknown.G2: foreign - event occurred in japan.The 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d9; g3; g6; h1; h2; h3; h4; h6; h11.Visual inspection of the returned device show that the dovetail feature is flared out.The devices also exhibit signs of insertion attempt/s (gouges, inserter marks).The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.This complaint is confirmed via product return.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: PERSONA ARTICULAR SURFACE FIXED BEARING PS RIGHT 10 MM HEIGHT
• 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: 21559861
• Report Number: 3007963827-2025-00080
• Device Sequence Number: 15735175
• Product Code: MBH
• UDI-Device Identifier: 00889024243750
• UDI-Public: (01)00889024243750(17)291022(10)66973895
• 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): 07/08/2025

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: Lay User/Patient
• Device Catalogue Number: 42522400710
• Device Lot Number: 66973895
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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