MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: china d10: unknown, tibial plate, unknown lot.Product has been received by zimmer biomet and 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 surgery the articular surface could not assemble with the mating tibial tray.The surgical technique was utilized; there was approximately a 5-minute delay.No harm occurred and no foreign bodies were retained.The procedure was completed with a different articular surface.Attempts have been made, and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: updated: a1; a2; a3; b4; b5; d2; d10; e1; e2; e3; g1; g3; g6; h1; h2.D10: 00598003701, stemmed tibial component precoat size 3 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten, 66700399.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information is 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; d2; g1; g3; g6; h1; h2; h3; h6.The reported was confirmed.Visual examination of the returned product identified flared out and compressed dovetail and wear consistent with usage of device.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 (lps-flex fixed bearing knee surgical technique).The root cause is attributed to a failure to follow instructions.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: NEXGEN ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51
• 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: 22896553
• Report Number: 0001822565-2025-03107
• Device Sequence Number: 14948955
• Product Code: JWH
• UDI-Device Identifier: 00889024211018
• UDI-Public: (01)00889024211018(17)281014(10)66284093
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: 66284093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 01/30/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/21/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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; SEEH11
• Patient Age: 66 YR
• Patient Sex: Female