MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR TIB BRG 12X63/67; PROSTHESIS, KNEE

Catalog Number	183422
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, on an unknown time-frame post implantation, it was reported that the inlay fractured.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).Medical product: unknown vanguard femoral component: catalog#ni, lot#ni; unknown vanguard articular surface: catalog#ni, lot#ni.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a2; b3; b4; b5; d1; d4; d6; d10; e1; e3; g3; g4; h2; h4; h6; h11.D10: medical product: vanguard cr ilok fem-lt 62.5: catalog#183026, lot#394680; biomet cc cruciate tray 67mm: catalog#141232, lot#j2798812.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty.Approximately ten (10) years and eleven (11) months post-implantation, the patient presented with instability and underwent revision surgery.It was revealed that the articular surface had fractured.The bearing was revised to a larger size without complication.The femoral and tibial components remain implanted.Due diligence is complete as multiple attempts have been made however all available information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Provided photograph confirms that the device is fractured.Further evaluation of the product could not be performed as no product was returned.Device history record was reviewed and no discrepancies related to the reported event were found.Revision operative notes state that patient was revised due to inlay fracture and instability.Tibial and femoral components found stable, and retained.Root cause was unable to be determined.Reported event was confirmed by review of provided photographs and medical records.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VANGUARD CR TIB BRG 12X63/67
• 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: 19075123
• Report Number: 0001825034-2024-00981
• Device Sequence Number: 4720477
• Product Code: JWH
• UDI-Device Identifier: 00880304001466
• UDI-Public: (01)00880304001466(17)280517(10)J6301550
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

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 Expiration Date: 08/31/2017
• Device Catalogue Number: 183422
• Device Lot Number: 594320
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 09/18/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/08/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2012
• 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 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female