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

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Additional 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 or Problem Description
Photos of product received.

• Brand Name: DISTAL FEMORAL XT COMPONENT SIZE C RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9980859
• Report Number: 0001822565-2020-01419
• Device Sequence Number: 3676809
• Product Code: KRO
• UDI-Device Identifier: 00889024195950
• UDI-Public: (01)00889024195950
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 08/27/2020; 10/07/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 08/28/2020; 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1