MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION STEM EXTENSION 3MM OFFSET SPLINED UNCEMENTED 17MM X +135MM; 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); Swelling/ Edema (4577)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is experiencing continual pain, persistent swelling and clunking sound upon movement approximately three (3) years following right knee arthroplasty.No intervention has been reported to date.Initial operative notes noted no intraoperative complications.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona revision femur cemented plus right size 7+ catalog #: 42504606212 lot #: 64600361, persona revision femoral distal augment cemented size 7, 7+ 5mm catalog #: 42556606205 lot #: 64799302, persona revision tibia fixed cemented right size e catalog #: 42542007102 lot #: 64679166, persona revision stem extension 6mm offset splined uncemented 15 mm x +135mm catalog #: 42560613515 lot #: 64628721, persona revision tibial augment cemented half block right medial size ef 5mm catalog #: 42555805405 lot #: 64835163, persona revision tibial augment cemented half block right lateral size ef 5mm catalog #: 42555805205 lot #: 64859459, persona revision tibial central cone size small catalog #: 42545000511 lot #: 64470409, persona posterior stabilized articular surface right 12mm catalog #: 42522600712 lot #: 64650132.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.
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.H6 - component code - proposed code is mechanical (g04) - stem.The product was evaluated through manufacturing review and the 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.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that the patient is experiencing continual pain, persistent swelling, stiffness and clunking sound upon movement approximately (4) years following right knee arthroplasty.No intervention has been reported to date.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.

• Brand Name: PERSONA REVISION STEM EXTENSION 3MM OFFSET SPLINED UNCEMENTED 17MM 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: 20321366
• Report Number: 0001822565-2024-03089
• Device Sequence Number: 20809120
• Product Code: JWH
• UDI-Device Identifier: 00887868250071
• UDI-Public: (01)00887868250071(17)291031(10)64559237
• 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: 2021
• 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): 12/08/2025

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: 42560313517
• Device Lot Number: 64559237
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 02/04/2025; 11/12/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 02/05/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2019
• 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: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White