MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE CD 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	00596202210
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: unknown tibial tray: catalog#ni, lot#ni.G2: foreign: india.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
It was reported that during an initial total knee arthroplasty, the articular surface would not seat properly on the tibial tray.The surgeon attempted to seat the bearing multiple times without success.No patient impact or adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified damage to the distal surface (nicked/gouged) and the locking feature (dovetail) is found to be flared out and compressed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the surgical technique.The root cause is attributed to use error.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE CD 10 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: 19070797
• Report Number: 0001822565-2024-01187
• Device Sequence Number: 4658328
• Product Code: JWH
• UDI-Device Identifier: 00889024210905
• UDI-Public: (01)00889024210905(17)281028(10)66310161
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/22/2024

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: 00596202210
• Device Lot Number: 66310161
• 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: 03/16/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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 H11 NARRATIVE.
• Patient Age: 58 YR
• Patient Sex: Female