MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD FEMORAL/TIBIAL IMPACTOR; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: the reported event occurred in mexico.The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during knee arthroplasty that while the surgeon was impacting the femoral implant with the femoral/tibial impactor, the polyethylene impactor head fractured in two (2).Upon collection of the fractured pieces, it was identified that the screw from the impactor could not be located.After a thorough search for the screw was conducted, the surgeon discovered that the impactor screw had become lodged within the medullary canal of the patient's femur.The procedure was completed with the retained screw.There is no plan to remove the screw at this time.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.H6 - component code - proposed code is mechanical (g04) - impactor.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
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.The following sections were updated: b4, d4, g3, h2, h3, h6.The following section was corrected: d4, h4, h6 (impact code).The reported event was confirmed via device evaluation.Visual inspection of the returned device identified signs of use (nicks, cracks, tool marks) and confirmed the pad is fractured.Not all fractured pieces were returned.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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.
Event or Problem Description
No additional information to report at this time.

• Brand Name: VANGUARD FEMORAL/TIBIAL IMPACTOR
• Common Device Name: INSTRUMENT, 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: 21525942
• Report Number: 0001825034-2025-00552
• Device Sequence Number: 15857806
• Product Code: HWA
• UDI-Device Identifier: 00880304349926
• UDI-Public: (01)00880304349926(10)Z19E2023
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/24/2025

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: 32-486201
• Device Lot Number: Z19E2023
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 06/13/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/20/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 80 KG