MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52 SUFFIX FEMORALS; PROSTHESIS, KNEE

Catalog Number	00596204010
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign country: china.D10: item#: 00598004701- stemmed tibial component precoat size 5 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten--- lot #: 66194513 customer 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 that the liner can't assemble mating tibial tray.The surgical technique was utilized; there was a 5 mins delay.There was no reported impact to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h4, h6, h11.Corrected: d6b (device was not implanted or explanted), g3.Visual examination of the returned device identified that the dovetail feature is compressed.The device also exhibits visible damage, gouges on outer profile, distal surface, and around dovetail features.Review of the device history record identified no related deviations or anomalies during manufacturing.The reported articular surface is compatible with the tibial tray.Review of complaint history identified additional similar complaint for the reported item and no additional complaints for part and lot combinations (for life time).Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Instructions for inserting the articular surface are provided in nexgen® lps fixed bearing knee surgical technique.The root cause is attributed to use error.Damage to the dovetail feature confirms the implant would not be able to seat.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 USE WITH LPS/LPS-FLEX 51 OR 52 SUFFIX FEMORALS
• 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: 22036397
• Report Number: 0001822565-2025-01432
• Device Sequence Number: 8177897
• Product Code: JWH
• UDI-Device Identifier: 00889024666092
• UDI-Public: (01)00889024666092(17)290909(10)66928369
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 09/23/2025

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: 00596204010
• Device Lot Number: 66928369
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 70 YR
• Patient Sex: Female