MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE ULTRACONGRUENT; 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.It was identified the sterile packaging was damaged at an unknown time.The tyvek lid on the sterile tray was opened and there is evidence adhesive transfer on the tray.No damage to the outer or sterile packaging was noted.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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

Not reportable as the sterility was not compromised.

• Brand Name: ARTICULAR SURFACE ULTRACONGRUENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8464469
• MDR Text Key: 140309679
• Report Number: 0001822565-2019-01348
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K070214
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00542802011
• Device Lot Number: 63018032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1