MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA NATURAL TIBIA; PROTHESIS, KNEE

Catalog Number	42532007102
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: psn tpr st 14 x +30 mm cat# 42557000114, lot# 67273145.Articular surface fixed bearing posterior stabilized (ps) right 10 mm height cat# 42522400710, lot# 67161739.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient was revised approximately one month post implantation due to the stem having dislodged from the tibial tray.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1 pt id and pt dob, g3; h2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following section was corrected: d4: udi#: 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 information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6; - visual examination of the provided photographs identified an explanted tibial plate and stem covered in bio-debris.The photos show the devices both separated and together.No product was returned therefore no further evaluations can be made.- review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.- devices are used for treatment.- the reported products were reviewed for compatibility with no issues noted.- pn (b)(4): review of complaint history found no additional related issues for this item and the reported part and lot combination.- radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ¿ ap and lateral views of the right knee show changes of knee arthroplasty without patellar resurfacing.¿ there is disassembly of the modular tibial component with malalignment/dislodgement of the stubby tibial stem extension with the main tibial tray component.- a definitive root cause cannot be determined.- no corrective actions, preventive actions, or field actions resulted after investigation of this event.- 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 information is available at the time of this report.

• Brand Name: PERSONA NATURAL TIBIA
• Common Device Name: PROTHESIS, 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: 23435784
• Report Number: 3007963827-2025-00428
• Device Sequence Number: 8689535
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: (01)00889024471061(17)350909(10)67222333
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42532007102
• Device Lot Number: 67222333
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 02/18/2026; 03/31/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/19/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female