MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA 0 DEG SPIKED KEEL LEFT SIZE F OSSEOTI TIBIA; PROSTHESIS, KNEE

Catalog Number	42535007501
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer 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.D10: additional associated products: 42512100812 persona articular surface medial congruent left 12 mm lot# 65752458.42508606401 persona cruciate retaining left size 8 pps std femur lot# 66126127.
Event or Problem Description
It was reported a patient began to experience limited range of motion and stiffness about one month post implantation.Patient underwent a manipulation under anesthesia about one week later with no complications.Following the manipulation, the patient continued to experience stiffness and limited range of motion and two weeks after the first mua a second manipulation was completed.In the months following, the patient presented with continued stiffness.Five months after the second manipulation, the patient underwent an arthroscopic lysis of adhesions and synovectomy due to arthrofibrosis.All implants remain in place and the event is improving.Suspected tibial overhang is noted in supplied records.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.D10: 42512100812 persona articular surface medial congruent left 12 mm lot#: 65752458 42508606401 persona cruciate retaining left size 8 pps std femur lot#: 66126127 42535007501 persona 0 deg spiked keel left size f osseoti tibia lot#: 66273434 42540200035 persona all-poly patella cemented 35 mm dia lot#: 66041659 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial; mua, preop rom 5-90*, mua performed without complications with rom 3-1258; mua continued stiffness and limited rom 80 degrees following mua.A second mua was completed to resolve.; arthroscopic arthrolysis: continued stiffness following mua and pt, diagnosed with left knee arthrofibrosis 4 months after mua.Left knee scope with synovectomy and lysis of adhesions on 5 months post mua, no implants exchanged.4 months later5: persistent left knee pain, intermittent swelling, concern of overhang, aspiration of fluid from left moderate knee effusion, cortisone injection in left knee, event resolving, patient declined study continuation due to ongoing left knee pain.The reported event was confirmed via medical records.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 0 DEG SPIKED KEEL LEFT SIZE F OSSEOTI TIBIA
• 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: 21987439
• Report Number: 3007963827-2025-00185
• Device Sequence Number: 19952814
• Product Code: JWH
• UDI-Device Identifier: 00889024631946
• UDI-Public: (01)00889024631946(17)340209(10)66273434
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/17/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42535007501
• Device Lot Number: 66273434
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American