MAUDE Adverse Event Report: ZIMMER GMBH NCB PLATE FOR FEMUR LEFT 9H; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Muscle/Tendon Damage (4532)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2.Report source: switzerland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00107 0009613350-2024-00108.

Event Description

It was reported that there was an initial procedure for an unknown femur fracture on an unknown date.Subsequently, the patient fell resulting in dislocated periprosthetic distal femoral fracture.Fracture reduction was completed, and an ncb plate, screws, and cerclage wires were implanted without complication.6 weeks later, the patient was revised again due to a fractured ncb plate.During the revision, two intermediate fragments of the femur were noted.Plate, screws, and 2 cerclage wires were implanted without complications.Diligence is complete and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.D10.Unknown screw.Unknown cerclage wires.The reported ncb plate as well as 8 screws and 5 screw caps were returned to the post market surveillance team for examination.A visual examination was performed, and the reported event of plate fracture can be confirmed.The plate has broken into two fragments.The fracture of the plate is located through a screw hole.On the fracture surfaces of both fragments of the plate, some beach marks are visible which point to a fatigue fracture.The fracture origins are located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are polished areas and some scratches, most probably due to contact between the parts after the fracture.Additionally, on the distal fragment of the plate, below the fracture area, there are some scratches, possible due to direct contact with the cerclage wire.Several additional scratches are visible on the surface of both the bone-facing and the non-bone-facing side of the plate.The screws have areas of thread damage.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.Undated radiographic images were provided and reviewed by a radiologist with the following assessment: ap and lateral views demonstrate a distal femoral fracture and a fractured lateral fixation plate with varus fracture angulation.Both cerclage wires are disrupted.The knee arthroplasty remains anatomically aligned.There is a partially healed proximal fibular fracture.Following revision with a longer plate, alignment is anatomic.Bone quality seems unremarkable.No abnormal radiolucency is noted.It should be noted that the cerclage wires used to reduce stabilize the bone fracture was placed around the bone and not over the implanted ncb plate.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.

• Brand Name: NCB PLATE FOR FEMUR LEFT 9H
• 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: 18942928
• MDR Text Key: 338149802
• Report Number: 0009613350-2024-00106
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 000889024297
• UDI-Public: (01)000889024297(17)240313(10)3116945
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K192217
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 02.03260.109
• Device Lot Number: 3116945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG