MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZSS DISTAL FEMORAL XT COMPONENT SIZE B RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

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

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery it was found out that some of the implants in the loaner set were delivered unsterile.Packaging box was closed with additional transparent adhesive tape.With same tape was closed first plastic box inside, white top cover paper was not hermetically closed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.No photos were provided or product returned.No evaluation can be performed.Review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.These products were likely conforming when they left zimmer biomet control.However, the products have been redistributed, and therefore, the root cause cannot be determined.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Photos received of the reported product found the inner sterile packaging and outer carton were both opened and resealed with clear tape.Sterility has been compromised.Medical records were not provided.Review of the device history records identified no related deviations or anomalies during manufacturing.These products were likely conforming when they left zimmer biomet control.It was determined that the product was not properly re-packaged during the return process.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: ZSS DISTAL FEMORAL XT COMPONENT SIZE B RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9979664
• MDR Text Key: 196645107
• Report Number: 0001822565-2020-01421
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• 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: 00585004202
• Device Lot Number: 64360081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1