MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CEMENTED POSTERIOR STABILIZED STANDARD FEMORAL COMPONENT RIGHT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is experiencing swelling and other unspecified post-operative complications approximately four (4) years following right knee arthroplasty.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10; concomitant devices - persona stemmed cemented tibial component right size g catalog #: 42532007902, lot#: 64306263, persona cemented all poly patella 35mm catalog#: 42540000035, lot #: 64825586, persona posterior stabilized articular surface right 10mm catalog#: 42521401010 lot#: 64091252.H6: component code - proposed code is mechanical (g04) femur.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
No additional information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, h2, h3, h6.The following section was corrected: d4, d5, h4.The reported event was unable to be confirmed.No devices or photographs were received; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.No medical records were provided.A definitive root cause could not be determined.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 CEMENTED POSTERIOR STABILIZED STANDARD FEMORAL COMPONENT RIGHT SIZE 10
• 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: 21731072
• Report Number: 3007963827-2025-00119
• Device Sequence Number: 4197053
• Product Code: JWH
• UDI-Device Identifier: 00889024229280
• UDI-Public: (01)00889024229280(17)290430(10)64302107
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42500606802
• Device Lot Number: 64302107
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male