MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN RHK ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW SIZE D 14MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).Concomitant medical products: nexgen option femoral component size e right, catalog #: 00588001502, lot #: 64401451.Unknown nexgen tibial component size 3, catalog #: ni, lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 during knee arthroplasty, the surgeon opted to utilize a size 3 tibial tray and a size e femoral component.At the time, the surgeon did not realize that the size e articular surface was not compatible with the size 3 tibial tray.After the implants had been placed, there appeared to be a few millimeters of overhang on both the medial and lateral side.In order to reduce the overhang and the risk of impingement, a smaller size d articular surface was used instead.However, it was identified after the procedure that the smaller articular surface was not compatible with the femoral component.Attempts have been made, however, no additional information is available at this time.
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.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-ray was provided but not reviewed.The root cause of the reported issue is attributed to user error as the surgeon used incompatible implants.Per package insert, 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.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 available at the time of this report.

• Brand Name: NEXGEN RHK ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW SIZE D 14MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11603084
• Report Number: 0001822565-2021-00925
• Device Sequence Number: 19738548
• Product Code: KRO
• UDI-Device Identifier: 00889024199316
• UDI-Public: (01)00889024199316(17)250331(10)64649604
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588004014
• Device Lot Number: 64649604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/09/2021; 07/29/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/28/2021; 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 NARRATIVE
• Patient Age: 61 YR
• Patient Weight: 85