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

Catalog Number	00596204210
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during final implantation of the articular surface prosthesis, the articular surface could not be properly placed and effectively locked, and it was removed and replaced with a new component.The event occurred intra-operatively during final implantation while following the surgical technique.There was no patient impact, no surgical delay attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D1: brand name.Articular surface use with lps/lps-flex 51 or 52 suffix femorals size gh 10 mm height.G2: foreign, event occurred in china.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further 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,d9,e1,e2,e3,g1,g3,g6,h1,h2,h3,h4,h6.The cmp was confirmed.Visual examination of the returned product identified flaring and compression of the dovetail feature with additional damage to the extraction slot, along with dings and gouges on the posterior corners.Review of the device history record identified no deviations or anomalies during manufacturing.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause is attributed to use error.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 nexgen lps fixed surgtech page 47.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.

• Brand Name: ARTICULAR SURFACE USE WITH LPS/LPS-FLEX
• 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: 23962286
• Report Number: 0001822565-2026-00052
• Device Sequence Number: 14639168
• Product Code: JWH
• UDI-Device Identifier: 00889024666214
• UDI-Public: (01)00889024666214(17)281029(10)66269991
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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 Catalogue Number: 00596204210
• Device Lot Number: 66269991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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 Sex: Unknown