MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 63MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant and packaging had residue on them prior to a knee procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs.Visual evaluation of the provided photo and feedback from sales rep confirmed the product was not packaged in the required pouch during manufacturing.The scuff marks and residue in the sterile blister are a result of the unprotected device shifting in the sterile packaging during transit.Device history record was reviewed and no discrepancies were found.The root cause of the reported event (missing sterile pouch) is the operator not following the work instructions provided.The root cause of the reported event (damaged blister and debris in sterile packaging) can be 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 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 information.Updated: b4, d9, g3, g6, h2, h3, and h10.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product confirms the device was not packaged in a poly pouch.Scuff marks and white debris are present inside the sterile cavity.The outer carton exhibits damage that can be attributed to the product being shipped back to the manufacturer, as the outer carton damage was not initially reported.No change to previous reported root cause.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET ILOK PRI TIB TRAY 63MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14431639
• Report Number: 0001825034-2022-01232
• Device Sequence Number: 5628739
• Product Code: JWH
• UDI-Device Identifier: 00887868247767
• UDI-Public: (01)00887868247767(17)290517(10)800100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2022

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: 141211
• Device Lot Number: 800100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 08/30/2022; 11/09/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 08/31/2022; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown