MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X14; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); Alteration In Body Temperature (2682)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 141205, biomet tibial locking bar, lot # 760940.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device's location being unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that patient underwent right knee procedure approximately 2 years ago due to pain, swelling, hot to the touch, fluid and mobility issues.Patient reports that she continued to experience the same symptoms and was revised about 8 months later where the tibial bearing was removed and replaced and excess synovium was removed.

Event Description

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

Manufacturer Narrative

(b)(4) reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: E1 VNGD PS TIB BRG 71/75X14
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8293911
• MDR Text Key: 134633057
• Report Number: 0001825034-2019-00403
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-183644
• Device Lot Number: 919930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 110