MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 17MM HEIGHT SIZE G WITH LOCKING SCREW STRIPED GREEN NEXGEN ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number	00599404217
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); Aseptic loosening (4883)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D4: attempts have been made to gather all product identification information, and no further information has been provided.G2: norway.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.
Event or Problem Description
It was reported that following a knee arthroplasty, the articular surface screw is loose and not seated in the stem.Attempts to obtain additional information have been made; however, no more information is available at this time.
Event or Problem Description
It was reported that a revision surgery has been scheduled due to a screw from the articular surface being loose and not seated in the stem.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d1, d2a, d2b, d4, d10, g1, g3, g4, g6, h1, h2, h4, h6, and h11 corrected: d6a.D10- medical product.Stemmed tibial component precoat size 6, item# 00598004702, lot# j6955456.Right size g cemented option femoral component, item# 00599401792, lot# 77011479.20mm diameter 100mm length straight stem extension combined length 145mm, item# 00598801020, lot# 65133523/ 15mm diameter 100mm length offset stem extension combined length 145mm, item# 00598802015, lot# 65091798.Distal femoral augment block precoat, item# 00599003710, lot# 63320433.Distal femoral augment block precoat, item# 00599003720, lot# 62998988.
Event or Problem Description
It was reported that a patient was revised approximately three years five and a half months post implantation due to due to a screw from the articular surface being loose and not seated in the stem.The screw from the insert was fractured, and a piece of the screw was still seated in the stem.The surgeon used a burr/drill to remove that bit and it will therefore not be retrieved.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b2, b3, b4, b5, d2b, d6b, d9, d10, g1, g3, g6, h1, h2, h6, and h11.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, d4, g1, g3, g6, h1, h2, h3, h6, and h11.Visual examination of the returned product identified signs of use (scratches, dings) and the treads are damaged.Also confirming complaint the locking screw has fractured, not all pieces returned.Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.Device was submitted for further analysis.Analysis determined that optical images of the device fracture surface show excessive smearing and indications of beach marks artifacts, suggesting that the device fractured due to fatigue.X-rays were provided and reviewed by mmi they state that there is dislodgment of the hinge post screw with resultant component malalignment.The metallic screw projects over the lateral joint line, consistent with disassembly of the hinge post.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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.

• Brand Name: 17MM HEIGHT SIZE G WITH LOCKING SCREW STRIPED GREEN NEXGEN ARTICULAR SURFACE
• 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: 23790114
• Report Number: 0001822565-2025-04484
• Device Sequence Number: 10465134
• Product Code: JWH
• UDI-Device Identifier: 00889024225299
• UDI-Public: (01)00889024225299(17)290103(10)64881870
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00599404217
• Device Lot Number: 64881870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/04/2026; 02/16/2025; 04/13/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/29/2026; 03/17/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown