MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-02567.D10-medical product 12mm height size e articular surface with hinge post extension item# 42512100810 lot# 65122273.H3- the product has been 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 a patient was revised due to a fractured hinge mechanism.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product identified both the returned articular surface and the hinge extension post are fractured.The devices were submitted for further analysis.Analysis determined the inferior side shows evidence of wear from rotating motion and a linear indentation, possibly resulting from misalignment of the bearing with the tibial tray under loading after fracture of the hinge post.The superior surface of the bearing shows evidence of possible light wear, abrasions, and burnishing which are typical with in-vivo use.The fracture of the uhmwpe bearing surface was possibly caused by overloading due to misalignment(s) within the knee system and possible impingement(s) after fracture of the hinge post.For the hinge post extension, optical images of the fracture surface show beach marks, ratchet marks and suspected primary and secondary crack initiation regions.Sem images shows typical step like fatigue fracture at higher magnification.The identified fracture surface artifacts suggest the fatigue failure mode.Material analysis found it is consistent with print specifications.Visual examination of the returned product identified the returned hinge post is fractured.The device was submitted for further analysis.Analysis determined sem imaging found evidence of step-like artifacts and ductile dimples.These fracture surface artifacts suggest the fatigue failure mode.Material analysis found it is consistent with print specifications.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.Complaint is confirmed with the returned implants.If any further information is received 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: LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT
• 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: 17906081
• Report Number: 0001822565-2023-02793
• Device Sequence Number: 20789124
• Product Code: JWH
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)231031(10)64082391
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 64082391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 01/10/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/07/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male