MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE EF 5-6 17MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address articular surface dislocation approximately four (4) years post-operatively.No additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - nexgen option cemented femoral component size f left catalog #: 00599601651, lot #: 65420250, nexgen option nonaugmentable tibial component size 5 catalog #: 00598604701, lot #: j6810072, nexgen standard all poly patella size 38mm catalog #: 00597206538, lot #: 65366449.The 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.

• Brand Name: NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE EF 5-6 17MM
• 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: 25001930
• Report Number: 0001822565-2026-01397
• Device Sequence Number: 9773624
• Product Code: JWH
• UDI-Device Identifier: 00889024666122
• UDI-Public: (01)00889024666122(17)261214(10)65225418
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596204017
• Device Lot Number: 65225418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• 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: 04/08/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male