MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PESONA SPIKED KEEL LEFT SIZE F OSSEOTI TIBIA; PRSOTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a clinical study that a patient had an initial left total knee arthroplasty.At the one year follow up, the patient reported severe pain and difficulty with daily activities.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42508606801; cruciate retaining left size 10 pps standard femur; 66278242.42512100810; articular surface medial congruent (mc) left 10 mm height use with tibia sizes e-f/cr femur sizes 8-11; 64740844.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.The event cannot be 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following.Findings: initial notification ¿the event was increased swelling/discomfort and decreased rom noted at about 6 weeks.Post-op.No reported fall or cause of the increased swelling.¿ ¿ findings are not captured in complaint at this time as they are not reflected or have resolved by the 3-month postop visit.(b)(6) 2024; 3 months postop.Slight-mild pain, moderate difficulties.Pain (b)(6), very satisfied.Rom 0-115.No pain medications, no abnormalities on xray.(b)(6) 2024; office notes.Patient continues to experience difficulty walking and leg weakness, currently performing minimal home exercise program and uses his power chair and walker for ambulation assistance.Patient continues to experience difficulty walking and leg weakness, currently performing minimal home exercise program and uses his power chair and walker for ambulation assistance.Incision well healed without concern, no tenderness to palpation, rom 0-120.X-rays show no concerns, implants in excellent position with no evidence of loosening, radiolucency, osteolysis, or wear.Patient has been dependent on a motorized wheelchair for quite sometime, encouraged patient to be as active as possible.Patient would like further pt, ordered.(b)(6) 2025; 1 year postop.Severe pain and problems.Pain (b)(6), neutral satisfaction.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.

• Brand Name: PESONA SPIKED KEEL LEFT SIZE F OSSEOTI TIBIA
• Common Device Name: PRSOTHESIS, 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: 22508532
• Report Number: 3007963827-2025-00283
• Device Sequence Number: 8736717
• Product Code: JWH
• UDI-Device Identifier: 00889024631946
• UDI-Public: (01)00889024631946(17)331215(10)66215223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/28/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 42535007501
• Device Lot Number: 66215223
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: Black Or African American