MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA PARTIAL FEMUR CEMENTED SIZE 5 LEFT MEDIAL; PROSTHESIS, KNEE

Catalog Number	42558000501
Medical Device Problem Codes	Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: austria.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.
Event or Problem Description
It was reported that the study site reported loosening of the femoral implant.The event is declared as 'unrelated' to the device and is tolerated.There are no current plans for revision.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Suggested code (annex g)- mechanical (g04) - femur.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.D10: additional associated products.42518200608 partial articular surface left medial size f 8 mmlot# 63726856.42538000601 partial tibial cemented size f left medial lot# 63661670.
Event or Problem Description
It was reported that as part of a study, the study site reported femoral loosening in zone 4/5 for the implant.Patient experiencing moderate pain at medial joint line, taking occasional nsaids, rom at 130 degrees, limping when walking because of knee.The event is declared as 'unrelated' to the device, and is tolerated.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
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: (b)(4).
Event or Problem Description
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: (b)(4).

• Brand Name: PERSONA PARTIAL FEMUR CEMENTED SIZE 5 LEFT MEDIAL
• 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: 21995224
• Report Number: 3007963827-2025-00186
• Device Sequence Number: 17221308
• Product Code: HSX
• UDI-Device Identifier: 00880304808485
• UDI-Public: (01)00880304808485(17)270930(10)63760852
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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: 42558000501
• Device Lot Number: 63760852
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/25/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/26/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 100 KG