MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD TIBIAL TRAY; PROSTHESIS, KNEE

Device Problem Malposition of Device (2616)

Patient Problems Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: vngd cr tib brg 16x63/67: catalog#183426, lot#166860; unknown vanguard femoral component: catalog#ni, lot#ni.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2023-02555.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event 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.

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.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

No further event information at time of this report.

• Brand Name: UNKNOWN VANGUARD TIBIAL TRAY
• Type of Device: 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: 18134664
• MDR Text Key: 328083721
• Report Number: 0001825034-2023-02666
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 102 KG