MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANFACTURING GMBH NCB®, FEMUR PLATE, LEFT, 13 HOLES, 324 MM; NCB PLATING SYSTEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 02/25/2022

Event Type  Injury  

Event Description

It was reported that the patient had a revision due to implant fracture.

Manufacturer Narrative

X-rays were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.No further due diligence required as all required information to support the conclusion is available or was already requested.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Review of x-rays: there are some x-rays available for investigation.It can be seen that the patient has existing knee prosthesis and a bone fracture.The post-op x-rays confirm the breakage of the ncb femur plate.Medical reports were not provided.The investigation did not identify a nonconformance or a complaint out of box (coob).The x-rays showed that a ncb femur plate was used for distal femur fracture with an existing knee prosthesis.For such fractures the ncb periprosthetic distal femur plate can be used as well.The ncb (non-contact bridging) peripros-thetic femur system is a line of polyaxial locking plates designed for the treatment of femur fractures, particularly peripros-thetic femur fractures.The ncb periprosthetic proximal and distal femur plates are wider in the area of the prosthesis and have offset holes that may allow bicortical screw placement in the area of the prosthesis.However, a definitive root cause for the fracture of the plate cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The complained products were returned for examination.The reported event can be confirmed.The ncb plate has fractured approx.Halfway of the plate and through the screw hole.The ncb cortical screws, cannulated screws and locking caps are mainly inconspicuous, with some signs of wear.Of note is that all the cancellous screws has scratches/thread lines on the shaft likely from insertion of the screws.On the fracture surfaces of the ncb plate, there are polished areas and some scratches, most probably due to contact between the parts after the fracture.On the fracture surfaces of the proximal part 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.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical reports were not provided.The investigation did not identify a non-conformance or a complaint out of box (coob).A definitive root cause for the fracture of the plate cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The plate as well as six cortical screws, five cancellous screws, two cannulated screw and five locking cap were returned to the product surveillance team for examination.The plate has fractured almost halfway of the length of the plate and through a screw hole.The cortical screws, cannulated screws and locking caps are mainly inconspicuous, with some signs of wear.Of note is that only five locking caps were returned, whereas in total eleven screws were implanted.All of the cancellous screws have thread lines on the shaft, likely from the insertion of the screws.On the smaller fracture surface of the distal part of the plate, some beach lines are visible, which point to a fatigue fracture.These beach lines are clearer on the distal part than on the proximal part.The fracture origin is located at the beginning of the chamfer on the non-bonefacing side.On the larger fracture surface of the distal part of the plate, no visible beach lines can be seen due to a polished surface, most likely due to direct contact between the fragments after the fracture.Review of the device history records identified no deviations or anomalies during manufacturing.The plate has fractured approximately at the area where the femur fracture occurred and around the area leading up to the big gap between femur and plate, as seen on the post-implantation radiological image.Examination of the fracture surface of the received plate points to a fatigue fracture.Fatigue fractures can occur due to a cyclic overloading, possibly due to a not properly healed bone fracture and / or non-adherence to the postoperative protocol (patient behavior).However, how and to what extent the previously mentioned factors in combination with a complex femur fracture, existing knee prosthesis, not all screws being implanted with a locking cap, as well as patient factors such as a high bmi (bmi=32) may have caused or contributed to the reported event remain unknown.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NCB®, FEMUR PLATE, LEFT, 13 HOLES, 324 MM
• Type of Device: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANFACTURING 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: 13927578
• MDR Text Key: 288670842
• Report Number: 0009613350-2022-00191
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297418
• UDI-Public: (01)00889024297418(11)170428(10)2907192
• Combination Product (y/n): N
• Reporter Country Code: KE
• PMA/PMN Number: K042695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 02.03260.113
• Device Lot Number: 2907192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 90 KG