MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ncb, screw, 5.0, 50 mm; catalog no#: 0203150050; lot#: unknown.Ncb, locking cap; catalog no#: 0203150300; lot#: unknown.Cerclage cable with crimp 1.8 mm dia.Cable 22 in.(559 mm) length; catalog no#: 00223200118; lot#: unknown.Therapy date: (b)(6) 2019.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to pain and breakage of the implant.The patient complained about pain, during routine examination the breakage was found.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the ncb plate was implanted on an unknown date and according to the provided x-rays revised on (b)(6) 2019 due to implant fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: in total 10 images of photographed x-rays have been received.The received file names are dated and some of the images contain stickers with the date or the date has been written on the x-ray by hand.(b)(6) 2009 the image shows an ap pelvis overview with a right total hip replacement.(b)(6) 2019 the image is of very low image quality due to insufficient image contrast, showing a right hip ap with proximal femur, an enclosed right tha and a periprosthetic right femur plate fixed with 4 visible screws and 2 cerclage wires.(b)(6) 2019 the image shows a right knee ap with distal femur and a femur plate fixed with 4 visible screws and 2 cerclage wires.(b)(6) 2019 two images, one right hip ap with enclosed tha and the proximal part of a periprosthetic femur plate fixed with 4 visible screws and 2 cerclage wires and one ap right knee with distal femur and visible femur plate fixed with 4 screws and 2 cerclage wires.(b)(6) 2019 two images of low image quality due to discoloration.Radiologically visible fracture of the periprosthetic plate and fracture of the femur between proximal and distal cerclage wire.(b)(6) 2019 two images, one ap right hip with proximal femur with visible periprosthetic femur plate fracture and femur fracture between proximal and distal cerclage wire and second view image of very low image quality showing a horizontal displacement of the distal fracture component.(b)(6) 2019 four x-rays showing the fracture reduction with an intramedullary nail and the proximal fracture component of the periprosthetic femur plate in-situ.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the ncb plate was implanted on an unknown date and revised on (b)(6) 2019 due to implant fracture.Radiologically clearly visible plate fracture on x-rays dated (b)(6) 2019; therefore, based on the received x-rays the reported ncb plate fracture can be confirmed.The product has not been received for investigation; therefore, product investigation and evaluation of the fracture surface could not be performed.Due lack of medical and patient records potential contributing procedure and patient factors such as bone quality, activity level, type of activity, relevant medical history and adherence to rehabilitation protocol are unknown.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a non-conformance or a complaint out of box (coob).Based on the unavailability of the fractured ncb plate and due to lack of medical and patient data, we were not able to identify a specific root cause for this issue.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, PROXIMAL, RIGHT, 15 HOLES, 324 MM
• Common Device Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9450730
• Report Number: 0009613350-2019-00789
• Device Sequence Number: 16795991
• Product Code: HRS
• UDI-Device Identifier: 00889024292703
• UDI-Public: 00889024292703
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 02.02263.015
• Device Lot Number: 2936975
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 09/22/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR