MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Crepitus (4893)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona trabecular metal posterior stabilized standard porous femoral component catalog #: 42500806601 lot #: 66470400, persona spiked keel osseoti tibial tray left size f catalog #: 42535007501 lot #: 66273431.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 the patient underwent a manipulation under anesthesia to address pain, stiffness and limited range of motion approximately six (6) months following left knee arthroplasty.Initial operative notes noted that the patient's range of motion was found to be satisfactory and the knee was stable varus and valgus stress in extension and flexion.No intraoperative complications.Manipulation operative notes noted the patient's range of motion was 5-85 degrees.The knee was gently manipulated into flexion and flexed to 115 degrees.The patient went to recovery in stable condition and no intraoperative complications were noted.
Event or Problem Description
No further event information 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, g3, g6, h2, h3, h6, h11.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g3, g6, h2, h6, h10, h11.
Event or Problem Description
It was reported that the patient underwent a manipulation under anesthesia to address pain, stiffness and limited range of motion at approximately six (6) months and ten (10) months following left knee arthroplasty.The patient continues to experience ongoing pain and limited range of motion.Initial operative notes noted that the patient's range of motion was found to be satisfactory and the knee was stable varus and valgus stress in extension and flexion.No intraoperative complications.Initial manipulation operative notes noted the patient's range of motion was 5-85 degrees.The knee was gently manipulated into flexion and flexed to 115 degrees.The patient went to recovery in stable condition and no intraoperative complications were noted.

• Brand Name: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM
• 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: 20419511
• Report Number: 3007963827-2024-00398
• Device Sequence Number: 12859499
• Product Code: MBH
• UDI-Device Identifier: 00889024237261
• UDI-Public: (01)00889024237261(17)280910(10)66033515
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512400712
• Device Lot Number: 66033515
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 02/04/2025; 07/24/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 02/05/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG