MAUDE Adverse Event Report: ZIMMER BIOMET, INC. #7 PE 50IN ZPLP EXT TOGGLELOC; TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE

Catalog Number	904754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Chills (2191); Fungal Infection (2419); Ambulation or Postural Difficulties (2544)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: compositcp 60 11x30mm int scr cat# 905263 lot# 195056.Anterior tibialis fz asp cat# (b)(6) serial# (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 4 months post implantation due to aseptic fungal infection, severe pain and ambulation difficulty.The patient was experiencing chills, night sweats, fever, and knee pain immediately after the initial procedure and this continued until the revision occurred where an acl graft and the hardware was removed.The patient has continued to have pain and mobility issues and an additional procedure to remove fungal growth occurred approximately 5 months post op.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported 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.

• Brand Name: #7 PE 50IN ZPLP EXT TOGGLELOC
• Common Device Name: TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21210719
• Report Number: 0001825034-2025-00189
• Device Sequence Number: 20853000
• Product Code: MBI
• UDI-Device Identifier: 00880304464858
• UDI-Public: (01)00880304464858(17)240702(10)P13205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/02/2024
• Device Catalogue Number: 904754
• Device Lot Number: P13205
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2019
• 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 Age: 38 YR
• Patient Sex: Male