MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA INSET ALL POLY PATELLA CEMENTED 26 MM DIA; PROSTHESIS, KNEE

Catalog Number	42540000026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: additional associated products.42522100313 articular surface medial congruent (mc) right 13mm lot# 63082258.42530006402 tibia trabecular metal 2-peg porous fixed brg rt size c lot# 77007244.42502205802 femur trabecular metal (cr) narrow porous lot# 64253326.G2: c.Nakasone, i.Weber, c.Israelite et al., (2025).Early radiographic evaluation of an anatomic porous tantalum tibia: a prospective, multi-center, non-randomized clinical study.The knee (53), 264-272.Https://doi.Org/10.1016/j.Knee.2025.01.010.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 through a journal article that during physical therapy, six months post implantation, the patient felt a pop while doing a sit to stand exercise and diagnosed with a fracture of the native patellar bone.The patient was instructed to stop flexion beyond ninety degrees, discontinue physical therapy, and the fracture was monitored through radiographic imaging at two week intervals.No surgical intervention was performed.
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.Corrected: d6b.D6b.: explant date was erroneously initially reported, as the device was not removed from the patient.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.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.The event 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA INSET ALL POLY PATELLA CEMENTED 26 MM DIA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22739289
• Report Number: 0002648920-2025-00212
• Device Sequence Number: 7198640
• Product Code: JWH
• UDI-Device Identifier: 00889024643680
• UDI-Public: (01)00889024643680(17)261231(10)64239734
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 42540000026
• Device Lot Number: 64239734
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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 Sex: Unknown