MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 17MM HEIGHT SIZE F ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a rotating hinge knee procedure.Subsequently, radiographs seem to indicate the hinge post has fractured.No revision procedure has been reported.
Additional Manufacturer Narrative
(b)(4).Medical product: unknown rhk femoral stem catalog#: ni lot#: ni.Right size f cemented option femoral component catalog#: 00588001602 lot#: 65117158.Unknown rhk tibial tray catalog#: ni lot#: ni.All poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#:.00597206535 lot#: ni.Foreign source: south africa.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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.D10 medical devices: right size f cemented option femoral component catalog#: 00588001602 lot#: 65117158 size 5 precoat cemented tibial component catalog#: 00588000500 lot#: 65136185 all poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#: 00597206535 lot#: 65089218 prc agmt block post sz f 10mm catalog#: 00599003602 lot#: 65077319 distal femoral augment block precoat size f 10 mm augment with screw catalog#: 00599003620 lot#: 64876689 trabecular metal tibial cone, medium 31x31mm catalog#: 00545001331, lot#: 64800315.15mm diameter 30mm length straight stem extension combined length 75mm catalog#: 00598801215, lot#: 64726397.17mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801017 lot#: 64691364 tibial block and screws precoat size 5 5 mm thickness catalog#: 00598800526, lot#: 64591047.Tibial block and screws precoat size 5 5 mm thickness catalog#: 00598800526, lot#: 64582086.Prc agmt block post sz f 10mm catalog#: 00599003602, lot#: 64506180.Allen medullary cement plugs 1-32 mm diameter flange/16mm diameter core catalog#: 00801102032, lot#: 63654486.Allen medullary cement plugs 1-28 mm diameter flange/14 mm diameter core catalog#: 00801102028, lot#: 65205176.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 patient underwent a right knee revision approximately a year post-implantation due to fracture of the hinge post.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It should be noted that g3 of the supplemental report, 0001822565 - 2023 - 00936 - 1, was reported incorrectly and should be april 5, 2023.Reported event was confirmed by review of radiographs.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: hinge post fracture of the right knee arthroplasty with resulting malalignment as noted.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 17MM HEIGHT SIZE F ARTICULAR SURFACE WITH HINGE POST EXTENSION
• 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: 16709309
• Report Number: 0001822565-2023-00936
• Device Sequence Number: 7362591
• Product Code: JWH
• UDI-Device Identifier: 00889024199446
• UDI-Public: (01)00889024199446(17)240430(10)64382625
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/07/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00588006017
• Device Lot Number: 64382625
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023; 05/08/2023; 06/30/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/27/2023; 05/31/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male