MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT HIGH FLEX PRECOAT RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number	5842-15-02
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface size 3 9 mm height femoral size a,b,c,d,e,f,g: catalog#: 00584202309, lot#: 63118426; tibial component precoat right medial/left lateral size 3: catalog#: 00584200302, lot#: 11017646.Multiple mdr reports have been filed for this report.Please see associated report: 0001822565-2023-00023.The product will not be returned to zimmer biomet for evaluation, as the product location is unknown.The investigation is in progress.Upon completion of the investigation, a follow up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right partial knee arthroplasty.Approximately six months post implantation, the patient felt their implanted knee give way and fell down a set of stairs.The fall resulted in a fractured humerus bone in the shoulder which required surgical intervention to resolve.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical g4-femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified possible loosening or malposition of the right medial uni knee compartment.Complaint not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: FEMORAL COMPONENT HIGH FLEX PRECOAT RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16091358
• Report Number: 0001822565-2023-00022
• Device Sequence Number: 2009633
• Product Code: HSX
• UDI-Device Identifier: 00889024193796
• UDI-Public: (01)00889024193796(17)251031(10)63199765
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 5842-15-02
• Device Catalogue Number: 00584201502
• Device Lot Number: 63199765
• Was Device Available for Evaluation?: No
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 108 KG