MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC TIB BRG 18X71/75; PROSTHESIS, KNEE

Catalog Number	183888
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060); Discomfort (2330)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 a patient was revised approximately eleven months post implantation due to loss of range of motion.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: debridement was completed the medial and lateral gutter, suprapatellar pouch, and under the quad & patellar tendon.Locking bar was removed along with previous poly and a 16mm trial poly was placed with good alignment and tracking.New definitive poly was snapped into place.No complications noted.Motion improved, patella tracks smoothly, excellent overall alignment, knee is stable.Radiograph report three views of l knee.Implants all look well aligned and well fixed.Patella tracks midline.Size and alignment look appropriate.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 by the provided medical notes.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.

• Brand Name: VNGD SSK PSC TIB BRG 18X71/75
• Common Device Name: PROSTHESIS, KNEE
• 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: 21571946
• Report Number: 0001825034-2025-00638
• Device Sequence Number: 15523850
• Product Code: HRY
• UDI-Device Identifier: 00880304440777
• UDI-Public: (01)00880304440777(17)240906(10)512940
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: Health Professional
• Device Expiration Date: 09/06/2024
• Device Catalogue Number: 183888
• Device Lot Number: 512940
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 06/16/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/02/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG