MAUDE Adverse Event Report: ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 14 MM; PROSTHESIS, KNEE

Model Number	5952-40-14
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial total knee replacement, the surgeon failed to install the articular surface.After closer inspection, an internal rim flaw was detected.There was no patient impact or surgical delay.A second device was inserted without issue.Attempts were made and no further information was provided.
Additional Manufacturer Narrative
(b)(4) concomitant medical product: unknown tibial tray: catalog#ni, lot#ni.Report source: foreign: (b)(6).Visual examination of the returned product identified distal surface damage (nicked/gouged) and that the dovetail feature is compressed and flared.Dhr was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Investigation results concluded that the reported event was due to use error.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the insert instrument.Detailed instructions for inserting the articular surface are provided in the relevant surgical technique document.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 14 MM
• Common Device Name: PROSTHESIS, KNEE
• MDR Report Key: 12753782
• Report Number: 0001822565-2021-03192
• Device Sequence Number: 11992176
• Product Code: JWH
• UDI-Device Identifier: 00889024208032
• UDI-Public: (01)00889024208032(17)250630(10)64590063
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 06/30/2025
• Device Model Number: 5952-40-14
• Device Catalogue Number: 00595204014
• Device Lot Number: 64590063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2020
• 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
• Patient Sequence Number: 1