MAUDE Adverse Event Report: ZIMMER BIOMET NORTHWEST TIBIAL TRIAL HANDLE

Model Number 32-486130

Device Problems Corroded (1131); Flaked (1246); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2017

Event Type  No Answer Provided  

Event Description

Biomet / zimmer on two occasions in the last 3 weeks has attempted to provide instruments to be used with total joint replacements that are worn, pitted, rusted, or with flaking paint.After direct communication with their sales reps and directors, we are still receiving instruments that are unsafe to use.I've attached pictures that included part numbers and lot numbers as well as general descriptions of what we are seeing.

• Brand Name: TIBIAL TRIAL HANDLE
• Type of Device: TIBIAL TRIAL HANDLE
• Manufacturer (Section D): ZIMMER BIOMET NORTHWEST ; natick MA 01760
• MDR Report Key: 6910914
• MDR Text Key: 88208020
• Report Number: MW5072572
• Device Sequence Number: 6
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017
• 22 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 32-486130
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1