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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This follow-up report is being filed to relay additional information.The following sections were updated: b4, d4, d9, g4, g7, h2, h4, h10.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: event occurred in china.The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported during knee arthroplasty that the articular surface could not be seated on the tibial tray.After several attempts, the surgeon identified that the articular surface implant was deformed.Another implant was used to complete the procedure after a forty-five (45) minute delay.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.Visual inspection of the returned device identified that the dovetail feature was compressed/flared out and damage was present in various areas.The device history records were reviewed and no discrepancies were identified.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before insertion.Detailed instructions for insertion are provided within the surgical technique.The root cause is attributed to failure to follow instructions.If any further information is found which would change or alter any conclusions or information, a supplemental 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 LPS-FLEX ARTICULAR SURFACE SIZE CD 10MM
• 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: 19859895
• Report Number: 0001822565-2024-02489
• Device Sequence Number: 15297346
• Product Code: JWH
• UDI-Device Identifier: 00889024211018
• UDI-Public: (01)00889024211018(17)281204(10)66404028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/23/2024

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 Model Number: N/A
• Device Catalogue Number: 00596203010
• Device Lot Number: 66404028
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 12/17/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/21/2024; 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 55 KG