MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL ARTICULAR SURFACE SIZE STRIPED YELLOW/E,F 10 MM HEIGHT; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2020

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 that the provisional broke during trialing.No further information is available at this time.

Manufacturer Narrative

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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows that the trial provisional was fractured and all pieces were returned.The device also exhibits signs of usage.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause is considered to be determined as normal wear and tear from repeated use during the instrument's field life.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

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

• Brand Name: PROVISIONAL ARTICULAR SURFACE SIZE STRIPED YELLOW/E,F 10 MM HEIGHT
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10682898
• MDR Text Key: 211453041
• Report Number: 0001822565-2020-03546
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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: 00599503212
• Device Lot Number: 60663005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 01/27/2021
• Supplement Dates FDA Received: 11/10/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1