MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA 0° SPIKED KEEL RIGHT SIZE G OSSEOTI TIBIA; PROSTHESIS, KNEE

Catalog Number	42535007902
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	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42502807002 - femur trabecular metal cruciate retaining (cr) standard porous - 65905292.42522100913 - articular surface medial congruent (mc) right 13 mm height use with tibia sizes g-h/cr femur sizes 8-11 - 66198414.42540500035 - 35mm diameter 9.5mm thickness osseoti porous 3-peg patella - 66583007.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
It was a patient had a right total knee arthroplasty.Approximately 5 weeks post-operative, the patient began to experience severe pain approximately.At the nine month post-operative follow-up appointment, the patient reported severe pain and difficulties with ambulation and adls.All radiographic imaging displayed no significant findings and the knee was stable upon assessment.A brace was given at the 9 month follow-up to rule out any instability that could be contributing to the ongoing pain.All products remain implanted.All available information has been provided.
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; h10.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had moderate to severe pain, diffuse rle lymphedema, rom 0-90 with total rom 105 degrees, flexion contracture of 1-5 degrees, and moderate problems walking and with adls.There were no significant x-rays findings.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
No further event information available at the time of this report.

• Brand Name: PERSONA 0° SPIKED KEEL RIGHT SIZE G 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: 22009042
• Report Number: 3007963827-2025-00192
• Device Sequence Number: 15427186
• Product Code: JWH
• UDI-Device Identifier: 00889024631977
• UDI-Public: (01)00889024631977(17)340429(10)66622038
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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 Catalogue Number: 42535007902
• Device Lot Number: 66622038
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: Black Or African American