MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIB POR 0 DEG SPK KEL E LT; PROSTHESIS, KNEE

Catalog Number	42535007101
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.At the 3 month follow up, the patient reported mild instability when loading the left ankle limiting her mobility.X-rays confirmed mild subsidence of the tibial component into valgus position.An exam revealed mild laxity with varus/valgus stress but full and pain-free range of motion.The patient stated she was still pleased with her surgery and did not want to pursue revision to correct the valgus deformity at that time.A knee brace was offered for stability.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant medical products: 42508606401 - femur - 66022883 42512100812 - articular surface - 66682051 184762 - patella - 67145617.110035368 - biomet bc r cement - av45ak1401.The device will not be returned for analysis, as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2 upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 3007963827.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 TIB POR 0 DEG SPK KEL E LT
• 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: 23300222
• Report Number: 0001822565-2025-03752
• Device Sequence Number: 4786983
• Product Code: JWH
• UDI-Device Identifier: 00889024631922
• UDI-Public: (01)00889024631922(17)350306(10)67186602
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42535007101
• Device Lot Number: 67186602
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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.
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Race: White