MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. 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
Additional Manufacturer Narrative
(b)(4) d10 - concomitant medical products: 42508606401 - femur - (b)(6), 42512100812 - articular surface - (b)(6), 184762 - patella - (b)(6), 110035368 - biomet bc r cement - (b)(6).The event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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.Attempts have been made and all available information has been provided.

• Brand Name: PERSONA TIB POR 0 DEG SPK KEL E LT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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: 24315168
• Report Number: 3007963827-2026-00053
• Device Sequence Number: 14671242
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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: 02/06/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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.
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Race: White