MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP E1 TIBIAL BEARING RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vgxp xp inlk pri tib tray catalog # 195752 lot # 716040, vgxp intlk femoral rt catalog # 195910 lot # 872820, vgxp xp e1 tib brg rl catalog # 195773 lot # 499430, series a pat std 31 3 peg catalog # 184764 lot # 703050, r & b bone cement catalog # unknown lot # 82054447.The complainant has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2020-01494, 0001825034-2020-01495, 0001825034-2020-01497, 0001825034-2020-01502.

Event Description

It was reported that the patient underwent right total knee arthroplasty.Subsequently, the patient has experienced pain, swelling and instability since her procedure.Patient falls often allegedly caused by the knee implants.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.The contact was sent the investigation results.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

No further event information available at the time of this report.

• Brand Name: VANGUARD XP E1 TIBIAL BEARING RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9937753
• MDR Text Key: 190018683
• Report Number: 0001825034-2020-01499
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K132873
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 195843
• Device Lot Number: 433370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 95