MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Joint effusion (4849)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona ultracongruent articular surface left 13mm catalog #: 42512200513 lot #: 65072786, persona cemented all-poly patella 35mm catalog #: 42540200035 lot #: 65885869, persona stemmed cemented tibial component left size f catalog #: 42532007501 lot #: 65844180.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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 left knee arthroplasty revision to address loss of range of motion and instability approximately sixteen (16) months post-operatively.The patient was revised to a posterior stabilized femur for increased stability and upsized to account for mid-flexion instability.Initial operative notes noted no intraoperative complications.Attempts have been made; however, no additional information is available.
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.H6 - component code - proposed code is mechanical (g04) - femur.Visual evaluation of pictures provided showed visible bio debris on the explanted articular surface and femoral component.Medical records provided confirmed the reported event.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.

• Brand Name: PERSONA CRUCIATE RETAINING STANDARD FEMORAL COMPONENT LEFT SIZE 8
• 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: 20818921
• Report Number: 3007963827-2024-00481
• Device Sequence Number: 7804045
• Product Code: JWH
• UDI-Device Identifier: 00889024230378
• UDI-Public: (01)00889024230378(17)330424(10)65763434
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 02/27/2025

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: 42502606401
• Device Lot Number: 65763434
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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: 80 KG