MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 2; INSTRUMENT, KNEE

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

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 tibia provisional is worn and cracked.No patient involvement.

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.Visual examination of the provided pictures identified signs of repeated use (nicks and gouges) and is chipped/fractured.The reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Per package insert, inspect all instruments/provisional carefully prior to each use.If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.The root cause of the reported issue was due to repeated use of the instrument for more than 15+ years field life; which causes wear and tear to the instrument and led to the fracture.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

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

• Brand Name: PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 2
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9612685
• MDR Text Key: 186530505
• Report Number: 0001822565-2020-00235
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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: 00598102702
• Device Lot Number: 60177441
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1