MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NEXGEN LPS-FLEX GSF OPT SZ D-R; PROSTHESIS, KNEE

Catalog Number	00576401452
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent a knee arthroplasty about four years ago.Patient is claiming/experiencing increasing pain, and bone scan revealed aseptic loosening per patient.No revision has been reported at this time.
Additional Manufacturer Narrative
(b)(4).Suggested code (annex g)- mechanical (g04) - femur customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.D10: additional associated products 00598002702 nexgen ps mic pre st tib plt sz2 lot# 62606389 unk nexgen bearing lot# unk.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.(b)(6) nexgen ps mic pre st tib plt sz2 lot# 62606389.(b)(6) articular surface size cd 10 mm lot# 64859868.(b)(6) all poly petella std cemented size 29mm dia 8.0mm lot# 64774846.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected, updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: visit 1: ap and lateral weightbearing x-ray views of the right knee show cemented total knee arthroplasty components.The femoral component alignment and position is grossly unremarkable.The tibial component exhibits approximately 4-5 degrees varus positioning.There appears to be wide radiolucent line underlying the medial tibial tray, as well as radiolucencies at tibial stem metal-bone interfaces suspicious for loosening.Radiolucent lines are also noted at metal-bone interfaces at the proximal tibial stem component anteriorly and at the posterior femoral component.Visit 3: ap weightbearing x-ray view of the right knee again shows varus positioning of the tibial component.Radiolucent line at the medial tibial tray-bone interface is suspicious for loosening.Elsewhere, there are thin nonspecific radiolucent lines at the tibial stem metal-bone interface medially and laterally.Visit 4 (pre-revision, no date): ap weightbearing x-ray view of the right knee again shows varus positioning of the tibial component, similar to prior exams.Since prior exam, there is increased radiolucency at the medial tibial tray metal-bone interface and increase in width of radiolucent lines at tibial stem metal-bone interfaces medially and laterally, consistent with loosening of the tibial component.Reduced bone mineral density is suggested radiographs at all 4 visits the event is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 GSF OPT SZ D-R
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22357966
• Report Number: 3007963827-2025-00262
• Device Sequence Number: 8081929
• Product Code: JWH
• UDI-Device Identifier: 00889024192249
• UDI-Public: (01)00889024192249(17)300531(10)64683685
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: Lay User/Patient
• Device Catalogue Number: 00576401452
• Device Lot Number: 64683685
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 10/15/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/10/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2020
• 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: Other
• Patient Sex: Female
• Patient Weight: 54 KG