MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2.Report source: australia.No product was returned, however a picture was provided.The pictures shows the explanted plate and 3 screws.As the plate appears to be fractured, event can be confirmed.A review of the device manufacturing records could not be performed due to missing lot number.Device is used for treatment.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of the complaint history identified additional similar complaints for the reported item.However, due to the lack of the lot number, an additional lot search could not be performed.Complaints are monitored per complaint trending process in order to identify potential adverse trends.The provided radiographed were reviewed from a radiologist.Plate and screw fixation are visible along the lateral aspect of the left femur, with an oblique distal femoral diaphyseal fracture noted.There is a fracture of the plate at the level of the osseous fracture, with fracture lucency remaining and slight lateral bowing of the femur centered at the level of the plate fracture.The fixation screws appear intact.Bone quality is markedly osteopenic.As there are no other femur fractures identified along the visualized fixation plate, it is suspected that this fracture represents non-union of the original femur fracture.This could be confirmed by correlation with earlier images before plate and screw fixation.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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 Description

It was reported that broken left distal ncb periprosthetic plate approximately 5 months post implantation.Plate has broken for no apparent reason that the surgeon knows of.Underlying fracture does not seem to have united since initial plating.Patient underwent a revision surgery.Diligence is complete and to date no additional information is available.

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 18 HOLES, 355 MM
• Type of Device: 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: 18670765
• MDR Text Key: 334920710
• Report Number: 0009613350-2024-00038
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0202264118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 91 YR
• Patient Sex: Male