MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE REGULAR CONSTRAINT 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	90597004012
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial total knee arthroplasty, the articular surface would not seat on the tibial tray.Another implant was used to complete the procedure without further complication.There was no patient impact and no adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown tibial tray: catalog#ni, lot#ni.G2: foreign: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or 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.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h11.Visual examination of the returned product found the distal surface to exhibit damage nicked/gouged and the dove tail locking features to be compressed and flared out.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event is attributed to use error.Detailed instructions for inserting the articular surface are provided in the surgical technique which indicates that damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.Complaint sample was evaluated and the reported event was confirmed.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: NEXGEN ARTICULAR SURFACE REGULAR CONSTRAINT 12 MM HEIGHT
• 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: 19286078
• Report Number: 0001822565-2024-01544
• Device Sequence Number: 20767058
• Product Code: JWH
• UDI-Device Identifier: 00889024644519
• UDI-Public: (01)00889024644519(17)290207(10)66558755
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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 Catalogue Number: 90597004012
• Device Lot Number: 66558755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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
• Patient Sex: Prefer Not To Disclose