MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEM; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: fem size e right catalog # 00588001502 lot # 11024768.G2: japan.H3: customer has indicated that the product will not be returned because it remains implanted.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 patient is experiencing perforated stem on femoral side four years post implantation.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
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Additional information does not affect the root cause.X-ray review indicates there is a right knee arthroplasty with additional femoral plate and screw fixation.The femoral implant stem protrudes through the anterolateral femoral cortex, and lucency is noted along the distal femur, indicating suspected loosening of the femoral implant.Irregular, chronic-appearing ossification is present medially, and the visualized plate and screws appear intact.The tibial implant fit and alignment are maintained, but the femoral implant is loose and shows malalignment due to the stem protrusion.Bone quality appears osteopenic.The report confirms the presence of a femur fracture and stem perforation.While there is no radiographic evidence of infection, the loosening and fracture with perforation could conceivably be related to an active infection.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.Updated: b4, b5, b6, d2, g1, g3, g6, h1, h2, h6.
Event or Problem Description
It was reported patient had infection that caused the perforation of the stem on femoral side four years post implantation.The stem penetrated through the bone causing the bone to fracture.Attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
It was reported patient is experiencing perforated stem on femoral side four years post implantation.The stem penetrated through the bone causing the bone to fracture.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: mechanical (g04) - stem.H6: failure of implant is n/a which was reported on initial report.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.

• Brand Name: NEXGEN STEM
• 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: 20708749
• Report Number: 0001822565-2024-03607
• Device Sequence Number: 12807132
• Product Code: JWH
• UDI-Device Identifier: 00889024220942
• UDI-Public: (01)00889024220942(17)300131(10)6465451
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598801010
• Device Lot Number: 64654451
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 03/20/2025; 03/25/2025; 04/16/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 03/28/2025; 04/15/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male