MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 16X63/67; PROSTHESIS, KNEE

Catalog Number	183426
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: vngd cr tib brg 16x63/67: catalog#183426, lot#166860; unknown vanguard tibial tray: catalog#ni, lot#ni.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2023-02666.Diligence is in process to determine whether the product is available for evaluation.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient presented with instability and a valgus deformity in the knee.Subsequently, a revision surgery was performed.During the surgery it was noted that the tibial component was slightly rotated and the inlay was sheared off at the posterior wall however the tibial and femoral components were free of visible deformities and were left intact.The surgeon replaced the articular surface with a thicker, anterior-stabilizing inlay to support and increase the patient's ligament tension.Due diligence is in progress for this event; to date no further information has been provided.
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.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The patient did not consent for evaluation of the explanted device.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient presents with knee instability, valgus leg deformity visible on exam; ¿when the inlay is removed, it is found that the posterior wall has been sheared laterally.¿ poly fragments removed with suction and forceps; surgeon states patient¿s morbid obesity, pcl insufficiency, and possible incorrect rotation of the tibial component could be contributing factors.Radiographs were provided but not reviewed as the x-rays provided were taken post-revision, therefore the review would not enhance the investigation.Root cause was unable to be determined.Reported event was confirmed by review of provided 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: VNGD CR TIB BRG 16X63/67
• 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: 18134665
• Report Number: 0001825034-2023-02555
• Device Sequence Number: 20509008
• Product Code: JWH
• UDI-Device Identifier: 00880304271081
• UDI-Public: (01)00880304271081(17)210816(10)166860
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 04/25/2024
• 2 Devices were Involved in the Event: 1 2

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: 08/16/2021
• Device Catalogue Number: 183426
• Device Lot Number: 166860
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2016
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 102 KG