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

Catalog Number	00576401552
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H6: component code: mechanical (g04) - femur.The device will not be returned for analysis, as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was the reported by legal that the patient underwent an initial right knee arthroplasty.Subsequently, the patient has experienced loosening and is being considered for a revision.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were 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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records provided and reviewed state that the patient underwent a right total knee arthroplasty.Operative details note that tibial and femoral components, a 14mm spacer, and a cemented patellar button were implanted with no intraoperative complications.Postoperative imaging confirmed appropriate alignment without fracture or acute abnormality.Per report from legal, the patient has subsequently experienced loosening of the implant, and a revision procedure is planned.A definitive root cause cannot be determined.This compliant cannot be confirmed.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.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event (the femoral component was found to be well fixed), it was determined to be not reportable.The initial report should be voided.
Event or Problem Description
It was reported that the patient was revised approximately (b)(6) post implantation due to loosening.During the revision the patella and femoral components were found to be well fixed, the tibial component was grossly loose.Upon receiving additional information of the reported event (the femoral component was found to be well fixed), it was determined to be not reportable.The initial report should be voided.

• Brand Name: NEXGEN LPS-FLEX GSF OPT SZ E-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 ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22004815
• Report Number: 3007963827-2025-00188
• Device Sequence Number: 13040069
• Product Code: JWH
• UDI-Device Identifier: 00889024192263
• UDI-Public: (01)00889024192263(17)290531(10)64283488
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2025

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: 00576401552
• Device Lot Number: 64283488
• Was Device Available for Evaluation?: No
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 11/04/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 08/25/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2019
• 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: Male