MAUDE Adverse Event Report: Zimmer Orthopaedic Mfg. Ltd. PERSONA TIB STM 5 DEG SZ E R; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous

Catalog Number	42532007102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total knee arthroplasty, vascular bleeding occurred immediately after implantation upon tourniquet release due to injury to the popliteal artery.The bleeding was identified intra-operatively after tourniquet deflation, haemostasis was performed, and the components that had been placed were removed during the same procedure, adding an additional two hours to the procedure.The patient was revised seven days later.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10.Concomitant medical products 42500605802 - psn fem ps cmt ccr - 67741829 unknown articular surface g2: foreign - event occurred in japan.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.

• Brand Name: PERSONA TIB STM 5 DEG SZ E R
• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous
• Manufacturer (Section D): Zimmer Orthopaedic Mfg. Ltd.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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 ; +1(574)526-0384
• MDR Report Key: 50411510
• Report Number: 3007963827-2026-00372
• Device Sequence Number: 10455134
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: (01)00889024471061(17)360423(10)67869076
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 42532007102
• Device Lot Number: 67869076
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2026
• 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: Unknown