MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Hematoma (1884); Pain (1994); Blood Loss (2597)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: kne-persona-bearings-unk; p/n: unk, l/n: unk.Kne-persona-femorals-unk; p/n: unk, l/n: unk.Kne-persona-tibial trays-unk; p/n: unk, l/n: unk.Kne-persona-patellas-unk; p/n: unk, l/n: unk.Customer has not indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565 - 2019 - 04551, 0001822565 - 2019 - 04552.

Event Description

It was reported that the patient experienced bleeding, blood clots, and extreme pain.Subsequently, an x-ray 4 years post implantation showed evidence of possible loosening.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 updated and additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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: UNKNOWN PERSONA TIBIAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9235374
• MDR Text Key: 165579682
• Report Number: 0001822565-2019-04553
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91