MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA; PROSTHESIS, KNEE

Catalog Number	42500607002
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Mechanical (g04) - femur.G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure approximately 2 years post implantation due to loosening.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; h2; h3; h6.Visual examination of the provided picture identified an explanted psn ps standard cemented femur.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.These devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Pn 42500607002 (psn ps standard cemented femur): review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and reviewed by mmi, they state that ap and lateral radiographs of the right knee show the presence of cemented femoral and tibial arthroplasty components, which appear intact.Radiolucent lines are present at the femoral component cement-bone interface anteriorly and at the femoral component metal-bone interface posteriorly, compatible with loosening of the femoral component.Radiolucent lines are also present at the tibial component plate metal-bone and cement-bone interfaces, consistent with loosening.The tibial component exhibits approximately 4 degrees of varus alignment, which, if present on postoperative images, poses a risk factor for tibial component loosening, though it is noted that varus alignment could also be a consequence of prosthetic loosening.Heterotopic bone is visualised at the medial joint line on the ap view, possibly fused with the medial tibial plateau, with a bony projection arising from the posterior tibial plateau on the lateral view.Loosening: a definitive root cause cannot be determined.Heterotopic ossification: the root cause of the reported issue is attributed to no problem found as heterotopic ossification is unrelated to the implanted zimmer biomet device.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is not confirmed.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 information is available at the time of this report.

• Brand Name: PERSONA
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24232948
• Report Number: 3007963827-2026-00030
• Device Sequence Number: 10229430
• Product Code: JWH
• UDI-Device Identifier: 00889024229303
• UDI-Public: (01)00889024229303(17)291031(10)64473103
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 03/18/2026

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: 42500607002
• Device Lot Number: 64473103
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2019
• 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