MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item number unknown, item name unknown screws, lot # unknown.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is available.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.(b)(4).This case was previously reported under 0001822565-2019-01004.
Event or Problem Description
It was reported that patient underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Event summary: it was reported that the product was implanted on (b)(6) 2017 and revised on (b)(6) 2017 due to ncb plate fracture.The patient was walking in partial support.Review of received data: a maven md reviewer case report is available.See results below: summary of imaging: pre-revision (image 2) dated on (b)(6).Ap of the distal left femur.Pre-revision (image 1) dated on (b)(6).Ap of the distal left femur.Assessment of imaging: image dated on (b)(6), demonstrates a lateral fixation plate of the left femur with multiple fixation screws and cerclage wires.Fracture lucencies are faintly visualized and the alignment appears anatomic.The tip of the femoral component of a left hip arthroplasty is visualized.Image dated on (b)(6), demonstrates interval fracture of the lateral fixation plate and femur at the mid-portion of the device.The femur fracture may be at the site of the original fracture.The distal femur is laterally displaced and there is slight over-riding at the oblique fracture site.There is varus alignment of the fracture.The fixation screws appear to be intact.The cerclage wire at the level of the fracture is displaced laterally with the distal femur.Impressions: fracture at the mid-portion of the lateral femoral fixation plate and femur as noted.Devices analysis: visual examination: the broken ncb pp plate, some screws, locking caps and cerclage wires were returned for investigation.The fracture of the plate is located through the middle of the eights screw hole (counted from proximal).On the fracture surfaces, beach lines 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 small polished areas and some scratches, most probably due to contact between the parts after the fracture.On the bone-facing side, close to the plate¿s sixth and eights screw hole there are two areas that show a mixture of smeared material and small polished indentations.These could possibly originate from contact with the bone, a cerclage wire or a screw/screw cap.Review of product documentation: all involved devices are intended for treatment.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) for the ncb pp plate have met the specifications valid at the time of production.The product combination was approved by zimmer biomet.Surgical technique: in the surgical technique it is described that ncb bone spacers may also be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire.Insert the bone spacers into ncb screw holes before plate insertion.Conclusion summary: it was reported that the product was implanted on (b)(6) 2017 and revised on (b)(6) 2017 due to ncb plate fracture.The plate was in vivo for approximately 2 months.The visual examination of the plate indicates that no material defects that could have triggered the fracture could be detected.The material analysis shows an indication for a fatigue fracture.There are several factors which may have contributed to the plate breakage.It can be the plate was overstressed during the in vivo time or a wrong patient behaviour can also be the cause for the breakage.On the bone-facing side of the plate there are polished areas and structured marks visible where the cerclage wire was placed.The surgical reports do not describe the use of bone spacers.In the surgical technique lit.No.06.02013.012 it is described that ncb bone spacers may also be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire.¿insert the bone spacers into ncb screw holes before plate insertion¿.Not using spacers might have led to high bending stresses where the plate was in direct contact with the cerclage wire (lever arm situation).The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information and performed investigation, an exact root cause for the plate breakage could not be determined.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9155055
• Report Number: 0009613350-2019-00587
• Device Sequence Number: 19428923
• Product Code: HRS
• UDI-Device Identifier: 00889024292901
• UDI-Public: 00889024292901
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 02.02264.115
• Device Lot Number: 2901771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 57