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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown articular surface catalog # unknown lot # unknown; unknown femoral component catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.Multiple mdr reports were filled for this event: 0001825034-2021-00353.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.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.X-ray review indicates there is joint space loss suggesting poly wear resulting in varus alignment of the knee.Overall fit and bone quality appears normal.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.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient will be considered for revision due to unknown reason.No revision procedure has been reported to date.Radiograph review suggests the patient is experiencing polyethylene wear resulting in varus alignment of the knee.Attempt for further information has been made, but no further information has been provided.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11279200
• MDR Text Key: 230285875
• Report Number: 0001825034-2021-00354
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other