MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST SCREW SIZE D 14 MM; PROSTHESIS, KNEE

Model Number	5880-40-14
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while receiving in a loaner implant kit, a warehouse team member noticed that it sounded like a loose piece was rolling around inside of the box.The box was opened and the inner packaging cavity was found to be broken with the hinge post extension screw was loose inside the box.Sterility of the device was compromised.
Additional 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; h2; h3; h6; h10.Visual evaluation of the returned product identified damage to the sterile packaging (inner and outer cavity).Sterility has been compromised.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event can be attributed to transit damage.The likely condition of the device when it left zimmer biomet is confirming to specification.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
No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST SCREW SIZE D 14 MM
• 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: 13891759
• Report Number: 0001822565-2022-00847
• Device Sequence Number: 17752750
• Product Code: JWH
• UDI-Device Identifier: 00889024199316
• UDI-Public: (01)00889024199316(17)221231(10)63843259
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 12/31/2022
• Device Model Number: 5880-40-14
• Device Catalogue Number: 00588004014
• Device Lot Number: 63843259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown