MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 14MM SIZE D ARTICULAR SURFACE W/HINGE POST EXTENSION; PROSTHESIS, KNEE

Catalog Number	00588004014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a revision left total knee arthroplasty to a rotating hinge knee approximately two years post implantation due to implant dissociation and hinge separation failure.The hinge component of the femur was removed and replaced, the articular surface poly and pin was replaced, and the tibial bushing was replaced as per surgical technique.
Additional Manufacturer Narrative
(b)(4).G2: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted additional associated products 00588001401 left size d cemented option femoral component femoral, lot # 64862658.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4, b5, d2a, g3, g6, h1, h2, h3, h4, h6, h10, h11.Visual examination of the provided photo identified multiple components consistent with a rotating hinge knee system, including a polyethylene articular surface, a femoral component, a metallic post, and associated modular hardware.The components appear explanted and exhibit visible blood residue.The articular surface and hinge post appear separated from one another, with the pin and bushing visibly disassociated.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Operative notes provided and reviewed state that the patient underwent a left knee arthroplasty and was revised about 2 years later, due to implant dissociation and hinge separation failure.The incident reportedly occurred when the patient was twisting out of a chair and felt a pop, after which he was unable to straighten his knee.During the revision procedure the hinge component of the femur was removed and replaced, the articular surface polyethylene and pin were replaced, and the tibial bushing was replaced as per the surgical technique.The femoral component itself was not revised.X-rays were provided and reviewed by mmi.They state that two views of the left knee demonstrated a left total knee arthroplasty with implant disassembly.A metallic component was noted centrally within the joint space.No anatomical or implant-related contributing factors to the hinge component dissociation were identified.Complaint is confirmed based on operative notes and x rays provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 event information available at the time of this report.

• Brand Name: 14MM SIZE D ARTICULAR SURFACE W/HINGE POST EXTENSION
• 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: 21526845
• Report Number: 0001822565-2025-00540
• Device Sequence Number: 8455152
• Product Code: KRO
• UDI-Device Identifier: 00889024199316
• UDI-Public: (01)00889024199316(17)250630(10)64723607
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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?: Yes
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 00588004014
• Device Lot Number: 64723607
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male