MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA CEMENTED 5 DEG STEMMED LEFT SIZE G; PROSTHESIS, KNEE

Catalog Number	42532007901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.Suggested code (annex g)- mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.D10: additional associated products 42502607401 persona femur cemented (cr) standard left size 12 lot# 64910165.
Event or Problem Description
It was reported the patient underwent a knee revision surgery due to pain from flexion/extension mismatch.The femoral and tibial implants revised.The articular surface also replaced at time of revision.
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.Suggested code (annex g)- mechanical (g04) - femur.Visual examination of the provided photos identified explanted total knee arthroplasty components, including a femoral component, tibial baseplate, and polyethylene insert.All components exhibit biological debris consistent with in vivo use.The polyethylene insert is marked ¿mc left ve¿ with part and lot information visible.The tibial and femoral components show residual cement.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Complaint is not confirmed.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.D10: additional associated products: 42502607401, persona femur cemented (cr) std left size 12, lot# 64910165.42512101011, persona articular surface (mc) left 11 mm, lot# 64764065.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA TIBIA CEMENTED 5 DEG STEMMED LEFT SIZE G
• 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: 21951943
• Report Number: 3007963827-2025-00179
• Device Sequence Number: 12970736
• Product Code: MBH
• UDI-Device Identifier: 00889024471092
• UDI-Public: (01)00889024471092(17)310414(10)65001961
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 06/19/2025

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: 42532007901
• Device Lot Number: 65001961
• 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: 05/30/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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 Sex: Male