MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE 12MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Catalog Number	00588005012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, between six to eighteen months post-implantation, the rotating hinge post backed out.The patient underwent revision surgery to replace the articular surface and hinge post.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).Implantation date occurred in 2021 though exact date is unknown.Concomitant medical products: unknown rotating hinge knee femoral component: catalog#ni, lot#ni; unknown rotating hinge knee tibial tray: catalog#: ni, lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for evaluation per hospital policy.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: right size f cemented option femoral component: catalog#00588001602, lot#64695386; 15mm diameter 30mm length straight stem extension combined length 75mm: catalog#00598801215, lot#64560563; size 4 precoat cemented tibial component: catalog#00588000400, lot#65069785; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#64995552; unknown stryker cement: catalog#ni, lot#ni, qty#3; unknown stryker cement restrictor: catalog#ni, lot#ni, qty#(b)(4).Additional information provided has prompted a review of the previously reported investigation results.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 total knee arthroplasty.Subsequently, seven (7) months post-implantation, the patient began to experience instability and underwent revision surgery where it was determined that the femoral hinge post extension disassociated from the articular surface.The polyethylene bearing was exchanged for a larger size and a new hinge post extension was locked into place.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: stability exam revealed instability to valgus stress with mechanical dissociation of the hinge apparatus; hinge post had dissociated from the femoral portion of the hinge and the tibial poly bearing was no longer stabilized.12mm poly was removed and replaced with 14mm poly.New hinge post was tightened manually then locked into place with torque wrench.No intraoperative complications were found.Investigation results concluded that the reported event is attributed to failure of the user to follow instructions.The reported products were reviewed for compatibility and it was determined that the implanted articular surface and femoral component are not compatible.Detailed instructions for properly matching components are provided in the ifu.The device instructions for use states the following: to properly match the components, the femoral and tibial component size must both be reflected on the articular surface label.Mismatching may result in poor surface contact and cause pain, greater wear, implant instability or otherwise reduce implant life.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.Reported event was confirmed by review of provided medical records.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: ROTATING HINGE 12MM HEIGHT SIZE E 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: 15814937
• Report Number: 0001822565-2022-03239
• Device Sequence Number: 5660936
• Product Code: JWH
• UDI-Device Identifier: 00889024199361
• UDI-Public: (01)00889024199361(17)250810(10)64649612
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/08/2025

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: 08/10/2025
• Device Catalogue Number: 00588005012
• Device Lot Number: 64649612
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 02/08/2023; 09/30/2024; 04/07/2025
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 02/10/2023; 10/24/2024; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male