MAUDE Adverse Event Report: ZIMMER GMBH NCB PP PR FEM PLT R18H L363MM; PLATE, FIXATION, BONE

Catalog Number	02.02263.018
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Periprosthetic fracture (4902)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: desc: femoral stem 12/14 neck taper std.Offset size 2 130 mm stem length; item: 00-8114-002-00; lot: 66268844.Desc: act artic e1 hip brg 28x46mm; item: ep-200152; lot: 66288654.Desc: zb 12/14 cocr hd 28mm x -3.5; item: 802202801; lot: 3195770.G2: foreign - event occurred in australia.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 medwatch 3500a will be submitted.
Event or Problem Description
It was reported the patient underwent primary surgery, and subsequently was revised due to a ncb plate fracture approximately 8 weeks post primary surgery.A new plate was implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.The product involved in the reported event was not returned for investigation; however, pictures were provided and review identified a ncb plate fractured in two pieces, at a hole level.The pictures also confirmed product information.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided and reviewed by a radiologist.The review identified ap and frog-leg lateral x-ray views of the right hip/femur at a single time point show presence of total hip arthroplasty with cpt femoral stem and fixation of femoral shaft fracture with ncb periprosthetic femur plate system.The distalmost femoral plate is excluded from view.The femoral stem component appears undersized.It is cemented laterally and at the tip, with a paucity of cement medially.Lucencies are present at the femoral stem cement-bone interface proximally, and at the distal femoral stem cement-bone and metal bone interfaces, consistent with loosening of the femoral stem.There is currently varus orientation of the femoral stem which may be sequela of the fracture.The baseline postop orientation of the femoral stem is not known in the absence of prior images.At the level of the distal femoral stem, a short oblique fracture of the femoral shaft is present which exhibits medial angulation of the distal fracture fragment.There is adjacent periosteal callus; however, this fracture appears to be grossly ununited.Distal femoral fracture has been treated with lateral ncb femur plate, bone graft, multiple screws and cerclage wires.The ncb femur plate has fractured at the level of fracture at the distal femoral stem and also exhibits medial angulation of the distal plate.The orientation of the proximal-most femoral plate screw suggests either bending deformity or fracture of the screw.There is radiolucency adjacent to the tip of this screw consistent with screw loosening.Generalized reduced bone mineral density is demonstrated.Cpt femoral stem exhibits loosening with periprosthetic femoral shaft fracture at the level of the distal stem.Risk factors for femoral stem loosening include generalized reduced bone mineral density, undersizing of the femoral stem and a paucity of cement.There is currently varus alignment of the femoral stem.If this alignment were present at baseline, it would also be a risk factor for femoral stem loosening and periprosthetic fracture.Other risk factors for periprosthetic fracture similarly include reduced bone mineral density, undersizing of the femoral stem and the use of the cpt femoral stem itself.Risk factors for ncb femoral plate fracture include ununited femoral fracture, loose femoral prosthesis and possibly varus alignment of the femoral stem (if present at baseline).A definitive root cause could not be determined.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.

• Brand Name: NCB PP PR FEM PLT R18H L363MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24301946
• Report Number: 0009613350-2026-00045
• Device Sequence Number: 9679538
• Product Code: HRS
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: Lay User/Patient
• Device Catalogue Number: 02.02263.018
• Device Lot Number: 3236353
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male