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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 00-5990-035-23 nexgen augment block distal, size e, 15mm lot# 63446102; 00-5990-035-20 nexgen distal precoat agmt block, size e, 10mm lot# 63419328; 00-5964-032-20 nexgen lps-flex fixed nsm art surf ef 3-4, 20mm lot# 63794048; 00-5988-021-12 nexgen offset stem ext 12mm dia x 200mm,(155mm) lot# 63620558.
Event or Problem Description
It was reported the femoral implant fractured where the set screw locks into the stem.The femoral implant was revised.The articular surface, stem and augments were revised as well.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  h6-component code- suggested code: mechanical (g4)- femur.Visual examination of the provided pictures identified a broken femoral component.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were not provided.This complaint has been confirmed by the picture provided.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: RIGHT SIZE E CEMENTED OPTION FEMORAL COMPONENT FEMORAL
• 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: 17491590
• Report Number: 0001822565-2023-02112
• Device Sequence Number: 7822123
• Product Code: JWH
• UDI-Device Identifier: 00889024224810
• UDI-Public: (01)00889024224810(17)300921(10)64794372
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 12/13/2023

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 Model Number: N/A
• Device Catalogue Number: 00599401592
• Device Lot Number: 64794372
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female