MAUDE Adverse Event Report: ZIMMER GMBH NCB PLATE FOR FEMUR LEFT 13H; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient experienced a pathological femoral fracture and underwent an open reduction and fixation with ncb plating system.Subsequently, approximately 9 months post-implantation, underwent a revision due to pain and fracturing of the ncb plate.Products were removed, bone graft was implanted due to delayed healing, and two plates and screws were implanted.Diligence is completed and no further information on the reported event have been provided.
Additional Manufacturer Narrative
(b)(4).D10.Ref 00223200418, lot 65812888, cerclage cable 1.8mm x 635mm.Ref 47223206001, lot 3155733, cable button for ncb polyaxial locking plate 2.5 hex drive.Ref 47223206001, lot 3155731, cable button for ncb prolyaxial lockign plate 2.5 hex drive.Ref 00223200418, lot 65776605, cerclage cable 1.8mm x 635 mm.Ref 47223206001, lot 3156779, cable button for ncb polyaxial locking plate 2.5 hex drive.Ref 290.20.280, lot unknown, kirsch wire w/trocar tip 2.0 m.Ref 02.03150.300, lot unknown, ncb locking cap.Ref 02.03152.060, lot unknown, ncb cancel screw 5.0 32 l60.Ref 02.03152.065, lot unknown, ncb cancel screw 5.0 32 l65.Ref 02.03152.070, lot unknown, ncb cancel screw 5.0 32 l70.Ref 02.03150.032, lot unknown, ncb screw 5.0 l = 32.Ref 02.03155.032, lot unknown, ncb scr d 4.0 self-tapping 32.Ref 02.03155.034, lot unknown, ncb scr d 4.0 self-tapping 34.Ref 02.03155.040, lot unknown, ncb scr d 4.0 self-tapping 40.Ref 02.03155.044, lot unknown, ncb scr d 4.0 self-tapping 44.G2.Report source: spain.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.The product was returned for investigation, and the issue can be confirmed: the plate is fractured into two parts through a screw hole.The surface of the plate that does not face the bone exhibits some scratches but is otherwise inconspicuous.The bone-facing side of the plate has a polished area near the fracture line.The features of the fracture surface indicate a fatigue fracture.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The medical records were provided and reviewed by a healthcare professional.Based on the investigation a fracture of the ncb plate can be confirmed and most likely attributed to fatigue.It could be assumed that the osteopenic bone quality and the unhealed fracture could be contributing factors to the plate failure.However, the extent to which these factors influenced the event remains unknown.In conclusion, since the cause may be multifactorial, consisting of patient- and procedure-related factors, a definitive root cause could not be identified.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
Diligence is completed and no further information on the reported event have been provided.

• Brand Name: NCB PLATE FOR FEMUR LEFT 13H
• Common Device Name: PROSTHESIS, TRAUMA
• 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 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19382744
• Report Number: 0009613350-2024-00191
• Device Sequence Number: 6367702
• Product Code: HRS
• UDI-Device Identifier: 00889024297418
• UDI-Public: (01)00889024297418(11)210128(10)3063323
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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 Model Number: N/A
• Device Catalogue Number: 0203260113
• Device Lot Number: 3063323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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 Age: 88 YR
• Patient Sex: Female
• Patient Weight: 48 KG