MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGAURD PS TIBIAL BEARING; PROSTHESIS KNEE

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: vanguard ps tibial bearing catalog # ep-183664 lot # 198810.(b)(6).Reporter had indicated that product will be returned.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: 0001825034-2018-02012.

Event Description

It was reported that during a total knee arthroplasty, the nurse noticed that the size printed on opening the sterile package label did not match with an actual implant size.Another device was used to complete the surgery.

Manufacturer Narrative

This follow up report is being filed to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection was performed on the returned products.The implant inside did not match the outside box or inner cavity labeling.Investigation results concluded that the reported event was due to manufacturing deficiency.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.Multiple mdr reports were filed for this event, please see associated report(s): 0001825034-2018-02013-1; 0001825034-2018-02012-1.

• Brand Name: VANGAURD PS TIBIAL BEARING
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7349269
• MDR Text Key: 102881981
• Report Number: 0001825034-2018-02013
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK113550
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: N/A
• Device Catalogue Number: EP-183642
• Device Lot Number: 210320
• Other Device ID Number: (01)00880304465701
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2289-2018
• Patient Sequence Number: 1