MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 8; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the tibial trial has cracked due to usage, which was found during cleaning.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned provisional confirmed the device has fractured.The device exhibits wear (scratches, nicks, gauges).Device history record (dhr) was reviewed and no discrepancies were found.Device was manufactured on august 16, 1996 and has therefore been in the field for approximately twenty three years and four months.It is unknown for how many times the device is being used.Based on the information available, root cause can be determined as normal wear from use during the instrument¿s field life.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

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

• Brand Name: PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 8
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9615916
• MDR Text Key: 189907492
• Report Number: 0001822565-2020-00245
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00598105702
• Device Lot Number: 75810000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 03/12/2020
• Supplement Dates FDA Received: 02/12/2020; 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1