MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-VANGUARD 360-FEMORALS-UNK; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: kne-vanguard xp-aug-unk, kne-vanguard xp-aug-unk, kne-vanguard xp-bearings-unk, kne-vanguard xp-tibial trays-unk, unknown femoral stem, unknown tibial stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product is unavailable by hospital policy.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: 0001825034-2020-01371.0001825034-2020-01372.

Event Description

It was reported that the patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, the patient was revised for pain due to instability and tibial overhang.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d1; d4; g4; g7; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was unable to be performed as the lot number of the device involved in the event is unknown.X-rays were provided and reviewed by a health care professional.Review found slight extension of the tibial plate medial to the tibial plateau (overhanging) possibly related to oversized tibial component.Alignment and bone quality appear normal with no signs of loosening, wear or radiolucency.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: KNE-VANGUARD 360-FEMORALS-UNK
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9909774
• MDR Text Key: 186744933
• Report Number: 0001825034-2020-01369
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K122160
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 195203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention