MAUDE Adverse Event Report: ZIMMER BIOMET, INC.; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Medical Device Problem Codes	Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42530008301 66301418 persona¿ natural tibia¿ trabecular metal.G2: foreign - event occurred in south africa.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure approximately 8 months post-implantation due to tibial component loosening and pain.Postoperatively, the patient developed knee pain, and at follow-up visits the surgeon identified progressive tibial component loosening on radiographs with minimal to no bone ingrowth at the bone¿implant interface.Intra-operatively during the revision, the tibial component was confirmed to be loose with minimal bone ingrowth, was removed, and replaced with a cemented tibial component with a stem and a polyethylene insert.Attempts to obtain additional information have been made; however, no more is available at this time.

• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
• 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: 24647524
• Report Number: 0001822565-2026-00858
• Device Sequence Number: 9842602
• Product Code: MBH
• UDI-Device Identifier: 00889024469419
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male