MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: report source 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 patient underwent right hip revision approximately 5 months post-implantation due to ncbâ®, periprosthetic femur plate broken.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: item # 02.02151.020, ncb unicortical scr 5.0 l=20mm, lot # 65047445.Item # 02.02150.300, ncb clamp-screw, lot # 3147776.Item # 02.02150.300, ncb clamp-screw, lot # 3146305.Item # 02.02150.300, ncb clamp-screw, lot # 3127011.Item # 02.02150.300, ncb clamp-screw, lot # 3035014.Item # 02.02150.075, ncb screw 5.0 l = 75, lot # 3119443.Item # 02.02150.070, ncb screw 5.0 l = 70, lot # 3121435.Item # 02.02150.060, ncb screw 5.0 l = 60, lot # 3113051.Item # 02.02150.055, ncb screw 5.0 l = 55, lot # 3109021.Item # 02.02150.050, ncb screw 5.0 l = 50, lot # 3131981.Item # 02.02150.050, ncb screw 5.0 l = 50, lot # 3034082.Item # 02.02150.036, ncb screw 5.0 l = 36, lot # 3140498.Item # 02.02150.036, ncb screw 5.0 l = 36, lot # 3136641.Item # 02.02150.032, ncb screw 5.0 l = 32, lot # 3119547.Item # 02.02150.026, ncb screw 5.0 l = 26, lot # 3153017.Item # 02.02150.060, ncb screw 5.0 l = 60, lot # 3113051.No product was returned for investigation, however pictures of the explanted plate, screws and cap were provided.The event can be confirmed as the plate is fractured.Nevertheless, due to the poor quality of the pictures, a deeper assessment is not possible.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.The imaging includes 2 ap and 2 cross-table lateral views of the right femur.The evaluation of the right hip arthroplasty is limited, but the alignment is maintained.A fracture is observed in the femoral fixation plate with slight displacement at the fracture site, though the cerclage wires remain intact.Multiple intraosseous screws are present below the plate, but they are not contiguous with it.Reparative bone formation is noted at the site of the plate fracture.In terms of the overall fit and alignment of the implants, there is no definite loosening, but there is slight malalignment at the fracture site.The bone quality is markedly osteopenic.Based on the available information, the reported event can be confirmed, however a definitive root cause cannot be established.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: NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM
• Common Device Name: PROSTHESIS, HIP
• 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: 19480224
• Report Number: 0009613350-2024-00219
• Device Sequence Number: 6932585
• Product Code: HRS
• UDI-Device Identifier: 00889024292857
• UDI-Public: (01)00889024292857(17)320825(10)3124686
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 0202264015
• Device Lot Number: 3124686
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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.; UNKNOWN CAPS.; UNKNOWN SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female