MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 11 MM DIAMETER +135 MM LENGTH; PROSTHESIS, KNEE

Catalog Number	42560613511
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately eleven months post implantation due to pain and tibial loosening.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10- medical product tibia fixed cemented right size g stem, item# 42542007902, lot# 65000253.Tibial perimeter cone right size large item# 42545001523, lot# 64923797.Articular surface fixed bearing (ps) right 13 mm height.Item# 42522401013, lot# 65034605.G2-australia.Visual examination of the provided pictures identified the explanted tibia with visible skin and blood on the surfaces.Item and lot numbers can be confirmed from the picture.No additional assessment can be made based on the provided picture.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: medical records findings: the patient presented with confirmed tibial leg pain and tibial loosening, with suspected infection.While no infection was found, the narrow-offset canal of the tibia caused a loss of fixation.After discussing options for a longer offset stem, the tibia was revised with a shorter stem.Radiographs findings: right total knee arthroplasty with possible loosening of the medial tibial component.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is confirmed based on the medical records provided.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue.To monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04) - stem.

• Brand Name: STEM EXTENSION 6MM OFFSET SPLINED UNCEMENTED 11 MM DIAMETER +135 MM LENGTH
• 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: 21686467
• Report Number: 0001822565-2025-00728
• Device Sequence Number: 12974293
• Product Code: JWH
• UDI-Device Identifier: 00887868250255
• UDI-Public: (01)00887868250255(17)310208(10)64963441
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 03/25/2025

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 Catalogue Number: 42560613511
• Device Lot Number: 64963441
• 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: 02/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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: Male
• Patient Weight: 85 KG