MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SERIES-A STANDARD PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Unstable (1667)

Patient Problems Muscle Weakness (1967); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard cr ilok fem-rt 67.5, catalog # 183010, lot # j3906939.Biomet fixed cruciate tibial plate, catalog # 141236, lot # j3672109.Palacos bone cement, catalog # 00111314001, lot # 85174547 qty: 2.Vanguard cr tibial bearing, catalog # 183462, lot # 520540.Customer has indicated that the product will not be returned because it remains implanted.Multiple mdr reports were filled for this event: 0001825034-2019-02905, 0001825034-2019-02906, 0001825034-2019-04614.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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 Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experiencing pain, instability, clunking, swelling, and loosening.No revision procedure has been reported to date.However, the patient is doing physical therapy to resolve the adverse events.Patient's medical records indicate that patient has atrophy/weakness in the right leg, buttocks, thigh and calf.Attempt for further information has been made, but no further information has been provided.

Event Description

It was further reported the patient's allegations occurred approximately one year post-implantation.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Event date - unknown month and day in 2018.Additional information received, does not change the previously reported root cause.

• Brand Name: VANGUARD SERIES-A STANDARD PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9184539
• MDR Text Key: 166309157
• Report Number: 0001825034-2019-04615
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 184766
• Device Lot Number: 128320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 66