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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument fractured when trialing.This resulted in a surgical delay of 5 minutes or less.There was no consequences or impact to the patient.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2022-02827.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2022-02827.

• Brand Name: 8MM THICKNESS SIZE F MEDIAL ARTICULAR SURFACE PROVISIONAL DO NOT IMPLANT
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15931767
• MDR Text Key: 305983090
• Report Number: 0001822565-2022-03400
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304809901
• UDI-Public: (01)00880304809901(10)63866008
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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: 42518100608
• Device Lot Number: 63866008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male