MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD XP INLK PRI TIB TRAY 71MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 195217 vngd xp intlk fmrl lt 67.5mm 835140; 184764 series a pat std 31 3 peg 228220; 195367 vgxp xp e1 tib brg ll 9x71 868160; 195437 vgxp xp e1 tib brg lm 9x71 868740.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Hospital sent the products to pathology.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee procedure and subsequently the patient was revised due to loosening and pain approximately five (5) years three (3) months post primary implantation.There is no additional information at this time.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The reported event was confirmed through visual evaluation of the provided picture of the explanted product.Bone cement and biological debris can be seen on the bottom of the tibial tray however, a detailed evaluation could not be performed as product was not returned.Medical records were provided and reviewed by a health care professional.Patient had ongoing pain for one year, full extension to 100 deg.Flexion, no instability and x-rays indicate sclerosis under the tibial tray.Patient had tibial loosening and was revised to a stemmed tibia.Radiographs were provided but not reviewed as they would not enhance the investigation at this time.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.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 XP INLK PRI TIB TRAY 71MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8605426
• MDR Text Key: 144876759
• Report Number: 0001825034-2019-02110
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 195249
• Device Lot Number: 846510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2019
• 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: 63 YR
• Patient Weight: 116