MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD FEM PEGS SET 2; PROSTHESIS, KNEE

Catalog Number 183099

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); Joint Laxity (4526)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: van ps open intl fem-lt 65: catalog#183128, lot#324010; vngd ps+ tib brg 20x71/75mm: catalog#183750, lot#794070; biomet offset tibial tray 75mm: catalog#141484, lot#ni; offset tib tray 2.5mm adaptor: catalog#141490, lot#ni; bmt splined knee stm 14x80: catalog#141614, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2024-00070; 0001825034-2024-00071.The customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, the patient underwent revision surgery due to instability and a deficient medial collateral ligament.The femoral components and articular surface were replaced without reported complication.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The followings sections have been updated: the investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

• Brand Name: VANGUARD FEM PEGS SET 2
• 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: 18484865
• MDR Text Key: 332562861
• Report Number: 0001825034-2024-00072
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 183099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/31/2024
• 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