MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL; INSTRUMENT, EXTREMITY

Model Number N/A

Device Problems Fracture (1260); Component Missing (2306)

Patient Problem Nervous System Injury (2689)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted late due to remediation efforts.  complaint sample was evaluated and the reported event was confirmed.As returned the impactor is fractured at the threads, the threads were left in the spacer and implanted in the patient.The hardness of the returned device was verified and it is within specification.Review of the device history records did not find any deviations or anomalies.Investigation results concluded that the reported event was due to a previously addressed design issue.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

It was reported the instrument fractured while in use and the foreign body was retained in the patient.No further information has been made available.

• Brand Name: TRABECULAR METAL
• Type of Device: INSTRUMENT, EXTREMITY
• 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: 6943202
• MDR Text Key: 89242008
• Report Number: 0001822565-2017-07023
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00430903900
• Device Lot Number: 60802913
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention