MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD RP INTLK STD TRAY 67; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - the event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.: remains implanted.

Event Description

It was reported that the primary total knee arthroplasty was performed with a vanguard.After the tibial tray was implanted with cement, a white stain was seen on the left posterior at the bearing trial step.The white stain was swept, but it could not be removed.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

(b)(4).Upon further review it was discovered that the united states did not have reporting responsibility.United kingdom owns that and will be reported according to their procedures and responsibilities.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.

• Brand Name: VNGD RP INTLK STD TRAY 67
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7572617
• MDR Text Key: 110458640
• Report Number: 0001825034-2018-03773
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 188004
• Device Lot Number: 2018011090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1