MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 6MM X 14MM X +135MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision cemented standard femoral component left size 9 catalog #: 42504606601 lot #: 64700001, persona revision central femoral cone size small catalog #: 42545001011 lot #: 64492745, persona revision cemented tibial component left size e catalog #: 42542007101 lot #: 64334575, persona revision straight splined uncemented stem extension 12mm x 135+mm catalog #: 42560113512 lot #: 64542404, persona posterior stabilized articular surface left 10mm catalog #: 42512600710 lot #: 64629118, persona revision cemented tibial augment half block left medial size ef 5mm catalog #: 42555805305 lot #: 64484558, persona revision cemented tibial augment half block left lateral size ef 5mm catalog #: 42555805105 lot #: 64352308, persona cemented all poly patella 35mm catalog #: 42540000035 lot #: 63295592, persona revision tibial central cone size x-small catalog #: 42545000510 lot #: 64572750, palacos bone cement catalog #: 5036963 lot #: 88844746, palacos bone cement catalog #: 5036963 lot #: 89194746 h6 - component code - proposed code is mechanical (g04) - stem.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 was experiencing pain approximately two (2) years following left knee arthroplasty.The patient was instructed to continue over-the-counter pain-relievers.No additional patient consequences were reported.Initial operative notes noted no intraoperative complications.
Event or Problem Description
It was reported that the patient was experiencing continued pain approximately two (2) years following left knee arthroplasty.The patient was instructed to continue over-the-counter pain-relievers.The patient also began experiencing moderate stiffness approximately five (5) years post-operatively.No additional patient consequences were reported.Initial operative notes noted no intraoperative complications.
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, h11.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA REVISION OFFSET SPLINED UNCEMENTED STEM EXTENSION 6MM X 14MM X +135MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21650745
• Report Number: 0001822565-2025-00686
• Device Sequence Number: 9276459
• Product Code: JWH
• UDI-Device Identifier: 00887868250286
• UDI-Public: (01)00887868250286(17)291130(10)64610752
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/23/2025

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: 42560613514
• Device Lot Number: 64610752
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 07/17/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White