MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING UC LEFT 11 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42511200611
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: lot: it was reported that the exact lot number of the device involved in the event is unknown as multiple lots had been used during the procedure.There are two potential devices that caused the reported event: 1.Potential lot (1): 64756739 - expiration date: apr 30, 2028 - udi: (b)(4).2.Potential lot (2): 64294853 - expiration date: aug 31, 2027 - udi: (b)(4).D10: medical product: tibia cemented 5 degree stemmed left size g: catalog # 42532007901, lot# 66819519 h4: manufacturing dates by lot: lot# 64756739: manufacturing date: apr 28, 2020 lot# 64294853: manufacturing date: aug 22, 2019.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the articular surface would not seat on the tibial tray.A secondary inserter and backup device were used to complete the procedure without further complication.There was no patient impact and no adverse events have been reported as a result of the malfunction.Due diligence is in progress for this event; to date no additional information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated/corrected: b4; b5; d4; g3; h2; h4; h11.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.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.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING UC LEFT 11 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: 21377890
• Report Number: 3007963827-2025-00055
• Device Sequence Number: 3772553
• Product Code: MBH
• UDI-Device Identifier: 00889024640719
• UDI-Public: (01)00889024640719(17)280430(10)64756739
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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: Health Professional
• Device Catalogue Number: 42511200611
• Device Lot Number: 64756739
• Was Device Available for Evaluation?: No
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 05/20/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/24/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2020
• 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