MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X71; PROSTHESIS, KNEE

Catalog Number 195402

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: vngd xp inlk pri tib tray, catalog # 195249, lot # 373020; vgxp xp e1 tib brg rl, catalog # 195332, lot # 514980; vgxp intlk fmrl rt, catalog # 195206, lot # 503630.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05932, 0001825034-2018-05945, 0001825034-2018-05957.Remains implanted.

Event Description

It was reported that the patient underwent a right knee arthroplasty.Subsequently, the patient suffered burning knee pain which was treated with aspiration and an injection.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

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.Dhr was reviewed and no discrepancies 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

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

• Brand Name: VGXP XP E1 TIB BRG RM 9X71
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7759474
• MDR Text Key: 116363880
• Report Number: 0001825034-2018-05998
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK122160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 195402
• Device Lot Number: 663070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 102