MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK STEM TIB TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.

Manufacturer Narrative

Reported packaging damage event was confirmed via visual examination.Visual inspection of the returned product identified that the outer box and sterile tray were crushed.It was identified the packaging was damaged in transit.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is attributed to transit damage.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 information is available.

• Brand Name: BIOMET ILOK STEM TIB TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8496827
• MDR Text Key: 141372733
• Report Number: 0001825034-2019-01647
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: N/A
• Device Catalogue Number: 141518
• Device Lot Number: 135480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1