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

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that some of the implants in the loaner set were delivered unsterile.The packaging box was closed with additional transparent adhesive tape.The first plastic box inside was closed with the same tape.The white top cover paper was not hermetically closed.Second plastic box´s top cover paper was opened too.There is no additional information available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No photos were provided or product returned; therefore, no evaluation can be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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

This follow-up report is being submitted to relay additional and/or corrected information.Photos of the reported product found the inner sterile packaging and outer carton were both opened and resealed with clear tape.Sterility has been compromised.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.Actions were taken to re-train the new team member.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

Photos of product received.

• Brand Name: DISTAL FEMORAL XT COMPONENT SIZE C RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9980859
• MDR Text Key: 197323317
• Report Number: 0001822565-2020-01419
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024195950
• UDI-Public: (01)00889024195950
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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: 00585004302
• Device Lot Number: 64360051
• 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