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

Catalog Number	00596001552
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 - concomitant medical products: 00598004701 - stemmed tibial component - (b)(6), 00596404010 - articular surface - (b)(6).G2: foreign - event occurred in guyana.H6: component code: mechanical (g04) - femur.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
It was reported that a right sided lps femoral implant was implanted on the left side.A revision surgery is to be booked in the near future.Attempts have been made, and no further information has been provided.
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 reported event was confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.X-rays were provided and reviewed by mmi, and the following was noted.Imaging findings - ap and lateral views labelled left knee show postoperative changes of knee arthroplasty without patellar resurfacing.The femoral component is longer medially than laterally which appears to correspond to the femoral component for the right knee per implant manual.There is soft tissue air in the anterior and medial knee suggestive of immediate postoperative status.Impression - immediate postoperative changes of left knee arthroplasty.The sticker sheets provided also confirm the implantation of the right sided implant into the left femur.The device history record was reviewed and no discrepancies relevant to the reported event were found.Patella - review of complaint history identified additional similar complaints for the reported item.Review of the part and lot combination identified 2 other complaints, of these 0 were for the same or similar issue.The root cause of the reported issue is attributed to use error.Within the instructions for use for the nexgen cr-flex and lps-flex fixed bearing knee, it is stated: 'do not use this product for other than labelled indications (off-label use)'.It is also noted within the ifu: 'check the appropriate knee implant size matching chart for component matching instructions.Mismatching may result in poor surface contact and could produce pain, decrease wear resistance, produce instability of the implant, or otherwise reduce implant life'.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.

• Brand Name: NEXGEN LPS-FLEX PRECOAT FEMORAL 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22578265
• Report Number: 3007963827-2025-00286
• Device Sequence Number: 9237719
• Product Code: NJL
• UDI-Device Identifier: 00889024001022
• UDI-Public: (01)00889024001022(17)291130(10)64595116
• Combination Product (Y/N): N
• Initial Reporter Country: GY
• PMA/510(K) Number: P060037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: Health Professional
• Device Catalogue Number: 00596001552
• Device Lot Number: 64595116
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 86 KG