MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 9 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: partial femur cemented size 5 right medial catalog#: 42558000502 lot#: 64512726, partial tibial cemented size e right medial catalog#: 42538000502 lot#: 64403090.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a partial knee replacement.Subsequently, approximately a month later, the patient was revised due to deep joint infection.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: a1, b3, b4, d7, g4, g7, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Revision operative notes were provided and it confirms that patient underwent revision due to infection.There was no pus, but there was a fair amount of synovitis and granulation tissue.Revision pre-operative follow up stated that patient had pain, swelling and stiffness.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

Event Description

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

• Brand Name: PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE E 9 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10080104
• MDR Text Key: 194310751
• Report Number: 0001825034-2020-01924
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304818248
• UDI-Public: (01)00880304818248(17)240831(10)64502889
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42528200509
• Device Lot Number: 64502889
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• 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
• Patient Weight: 81