MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Catalog Number	42502207001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.H6: mechanical (g04), femur.H3: customer has indicated that the product will not be returned because product location is unknown.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 patient underwent a revision procedure four months post implantation due to fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10 - medical product: all-poly patella cemented 38 mm diameter catalog # 42540200038 lot # 66035909 tibia cemented 5 degree stemmed left size f catalog # 42532007501 lot # 66748902 poly 12 mm catalog # unk lot # unk.
Event or Problem Description
It was reported patient underwent a revision procedure four months post implantation due to periprosthetic fracture.Femur was exchanged with plates, screws and cables.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h4; h6; h11.H6: component code: mechanical (g04) - femur.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 and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no operative notes provided; surgery planning provided only.Radiographs showed left total knee arthroplasty with comminuted fracture of the distal femoral diaphysis in a periprosthetic location.Osteopenia.A definitive root cause cannot be determined.Complaint confirmed via provided x-rays.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 FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR)
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21841359
• Report Number: 0001822565-2025-00998
• Device Sequence Number: 7963265
• Product Code: OIY
• UDI-Device Identifier: 00889024470156
• UDI-Public: (01)00889024470156(17)340521(10)66509795
• 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 Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2025

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?: No
• Device Catalogue Number: 42502207001
• Device Lot Number: 66509795
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 06/12/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male