MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE E 8 MM THICKNESS DO NOT IMPLANT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the returned trial confirmed that the device has fractured and the device exhibits signs of usage.Dimensional analysis performed found the device is within specification.The dhr was reviewed and no discrepancies relevant to the reported event were found.No medical records were provided.The device was manufactured on (b)(6) 2018 and has been in the field for approximately one year and ten months.It is unknown for how many times the device is has been used.Based on the information available, a root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported during the initial total knee arthroplasty the articular surface provisional fractured when surgeon removed it.No adverse events have been reported as a result of the malfunction.

• Brand Name: ARTICULAR SURFACE PROVISIONAL MEDIAL SIZE E 8 MM THICKNESS DO NOT IMPLANT
• 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: 10111622
• MDR Text Key: 199838943
• Report Number: 0001825034-2020-02209
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304809840
• UDI-Public: 00880304809840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42518100508
• Device Lot Number: 63904334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1