MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CEMENTED TIBIA; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure two days post implantation due to wrong tibial component used.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: articular surface, catalog #: 42522100810, lot #: 65863775.Cruciate retaining, catalog #: 42508606602, lot #: 65754640.Fix fluted pin, catalog #: 20800000010, lot #: 65999720.Fix fluted pin, catalog #: 20800000011, lot #: 66001515.Navitracker kt a knee & spine, catalog #: 20800000007, lot #: 052323a4.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
It was reported patient underwent a revision procedure two days post implantation due to wrong tibial component used.Post-operatively it was recognized that a cemented component was opened and placed in the surgical field when a press-fit tibial component was requested.The patient was revised on with exchange to the correct tibial component and replacement of the articular surface.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; section h6 was corrected.The event is confirmed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision of the right tibial component under general anesthesia (estimated blood loss: 100cc) due to the inadvertent implantation of a cemented tibial component during a knee replacement procedure earlier that week.The arthrotomy was reopened, sutures removed, and the tibial bearing and component were carefully extracted without bone loss or damage to the keel punch.A press-fit tibial component, which had originally been intended, was correctly implanted with an excellent fit, and the bearing was replaced without difficulty.The surgery was successful, achieving satisfactory stability and range of motion, and the patient was transferred in stable condition to recovery, to be discharged home with a follow-up clinic appointment.The root cause of the reported issue is attributed to off label use.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.

• Brand Name: PERSONA CEMENTED TIBIA
• 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: 20084684
• Report Number: 0001822565-2024-02775
• Device Sequence Number: 15406589
• Product Code: JWH
• UDI-Device Identifier: 00889024632134
• UDI-Public: (01)00889024632134(17)321108(10)65644709
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42536007502
• Device Lot Number: 65644709
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 01/30/2025; 07/23/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 02/18/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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