MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Event occurred in the (b)(6).

Event Description

It was reported that approximately 1 month post implantation, the patient was revised due to infection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g4, g7, h2, h3, h6, h10.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.A definitive root cause could not be determined with the information 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.

Event Description

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

• Brand Name: ARTICULAR SURFACE WITH HINGE POST EXTENSION
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9744056
• MDR Text Key: 180542609
• Report Number: 0001822565-2020-00652
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024199378
• UDI-Public: (01)00889024199378
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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: 00588005014
• Device Lot Number: 64345158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention