MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM; TRAUMA, PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent right lower extremity and hip revision approximately 5 months post-implantation due to fractured femur.Stem, head and ncb plate/screws explanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: item # 00811400110, femoral stem 12/14 neck taper ext.Offset size 1 130 mm stem length, lot # 64997965.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g3, g6, h2, h3, h6, h11.D10: item # 00811400110, femoral stem 12/14 neck taper ext.Offset size 1 130 mm stem length, lot # 64997965 item # 02.03150.042, ncb screw 5.0 l = 42, lot # unknown item # 02.03155.038, ncb scr d 4.0 self-tapping 38, lot # unknown item # 02.03150.040, ncb screw 5.0 l = 40, lot # unknown item # 02.03155.036, ncb scr d 4.0 self-tapping 36, lot # unknown item # 02.03155.040, ncb scr d 4.0 self-tapping 40, lot # unknown item # 02.03155.042, ncb scr d 4.0 self-tapping 42, lot # unknown item # 02.03150.038, ncb screw 5.0 l = 38, lot # unknown item # 02.03150.036, ncb screw 5.0 l = 36, lot # unknown.No product was returned for evaluation.Visual examination of the provided pictures shows the explanted plate, screws and the stem.The stem is entered under (b)(4).On the picture showing the ncb pp plate, it can be recognized that the plate is fractured in two fragments.The plate fracture can be confirmed.A review of all relevant device manufacturing records for the plate 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.Radiographs were provided and reviewed by a health care professional/radiologist."a right hip arthroplasty with apparent acetabular revision and constraining ring is present.There are two lateral femoral plates with multiple screws and cerclage wires.There is a fracture of the femoral diaphysis with varus alignment and the shorter plate is separated from the femur.The fracture extends to the tip of the femoral implant.A plate fracture cannot be excluded but is not visualized.Several screws are fractured." with the available information, 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 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, PROXIMAL, RIGHT, 18 HOLES, 363 MM
• Common Device Name: TRAUMA, PLATE, 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 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20785659
• Report Number: 0009613350-2024-00547
• Device Sequence Number: 13013231
• Product Code: HRS
• UDI-Device Identifier: 00889024292710
• UDI-Public: (01)00889024292710(17)321205(10)3140616
• 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): 12/13/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0202263018
• Device Lot Number: 3140616
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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; SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male