MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIAL TRAY; PROSTHESIS, KNEE

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a journal article that twelve knees implanted with a constrained condylar knee system in revision total knee arthroplasty were subsequently revised due to infection.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4).D4: attempts have been made to gather all product identification information, and no further information has been provided.D10- medical product.Unknown articular surface.Unknown femoral.G2- canada.G2- greenberg, a., braunstein, d., abughaduma, n.R., gross, a., safir, o., kuzyk, p., wolfstadt, j., backstein, d.(2025).Survivorship and complications in revision total knee arthroplasty with a constrained condylar knee implant: a minimum 10-year follow-up study.The journal of arthroplasty, volume 40, issue 12, 3240 - 3245.Doi: 10.1016/j.Arth.2025.05.088.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: UNKNOWN TIBIAL TRAY
• 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: 24743217
• Report Number: 0001822565-2026-01013
• Device Sequence Number: 8639768
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• 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: 03/11/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown