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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure due to a bone fracture.The patient fell and sustained a diaphyseal femur fracture of her right hip which was initially treated with the placement of an 18-hole proximal ncb plate.Approximately a month later, the patient experienced acute pain when turning over and felt it crack resulting in her not being able to sit after.On x-ray it was seen that the plate has come off just above the fracture.There is also a suspicion of infection as the wound was red and warm.The patient was revised approximately 1 week later.Due diligence has been completed for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
(b)(4).G2: foreign: sweden 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.Two undated ap radiographs of the right hip were provided and reviewed by a radiologist.The first image, taken before the implantation of the plate, shows a right femoral diaphyseal fracture with mild displacement and varus angulation, while the hip arthroplasty remains anatomically aligned.The second image, allegedly taken before revision surgery, reveals the placement of a lateral plate with multiple screws.However, the plate is fractured at the level of the original fracture, which now appears comminuted with worsened varus angulation.The hip arthroplasty alignment remains unchanged.The bone quality appears osteopenic.The plate was returned for investigation together with some fixation screws.The event can be confirmed as 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 some polished areas.The fracture surfaces exhibit signs of damage, likely resulting from reciprocal contact after the fracture occurred; however, the undamaged areas display features that indicate a fatigue fracture.A review of the device manufacturing records confirmed no abnormalities or deviations.Based on the analysis of the retrievals, a fracture of the plate can be confirmed and is most likely attributed to fatigue.Review of the manufacturing records confirm that the product was manufactured according to specification; therefore, it is not expected that the manufacturing process contributed to the reported issue.A possible infection is reported, but not confirmed.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.During the investigation process a review of the sterile certifications was performed and it confirmed that all devices were manufactured following acceptable sterilization processes according to published iso/aami/astm & eu guidelines.The extent to which the suspected infection may have influenced the reported event remains uncertain.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
No additional event information to report at this time.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM
• Common Device Name: NCB TRAUMA IMPLANT
• 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: 20517272
• Report Number: 0009613350-2024-00493
• Device Sequence Number: 7718692
• Product Code: HRS
• UDI-Device Identifier: 00889024292710
• UDI-Public: (01)00889024292710(17)331209(10)3179547
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 01/17/2025

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: 0203263018
• Device Lot Number: 3179547
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2023
• 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 Sex: Female
• Patient Weight: 50 KG