MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented with sudden pain, thigh edema and total impotence approximately 4 months post implantation.It was found by ct scan that the plate had fractured.The patient underwent surgery to remove the plate and osteosynthesis of the right femur.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): g2: report source france.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
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, 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 features of the fracture surface indicate a fatigue fracture.Two radiographic images of the right knee preoperative and postoperative were provided.A comminuted fracture of the right femur can be seen in the postoperative image.However, no further assessment is made, as no further images were provided since the onset of the reported pain.The surgical report for implantation surgery was provided and reviewed by a health care professional.The review identified a three part fracture of the right femur with osteosynthesis and no intraoperative complications.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Based on the investigation a fracture of the ncb plate can be confirmed and most likely attributed to fatigue.However, 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
No further event information available at the time of this report.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 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: 20771971
• Report Number: 0009613350-2024-00544
• Device Sequence Number: 4412956
• Product Code: HRS
• UDI-Device Identifier: 00889024297562
• UDI-Public: (01)00889024297562(10)3096826
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/20/2024

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: 0203264012
• Device Lot Number: 3096826
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG