MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 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	Fall (1848)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received 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.(b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Investigation results were made available.Additional: d11, h2, h6; correction: d3; b4, b5, d10, g4, g7, h3, h10 event description: it was reported that the ncb plate was implanted on (b)(6) 2020 and revised on (b)(6), 2020 due to a fracture of the plate.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: seven views of the right femur demonstrate a spiral fracture of the distal femoral diaphysis with apex lateral angulation of the fracture fragments.Right total hip arthroplasty in place.Extensive vascular calcification.A lateral plate and screw fixation device is placed to fixate the fracture with multiple cerclage wire seen.A second plate is placed medially on image six and seven.Overall fit and alignment of the implant is appropriate.A reported plate fracture is not seen on these images.Surgical report: surgical report, dated (b)(6), 2020: only the first page of the surgical report (revision) was available.However, no conspicuous findings relevant to the reported event have been identified.Product evaluation: visual examination: the broken ncb pp plate was returned for investigation.The plate was broken in two fragments.The fracture of the plate is located through a screw hole.The fracture surfaces show also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Several scratches are visible on the surface of the non-bone-facing side of the plate.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.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 (b)(6), 2020 and revised on (b)(6), 2020 due to a fracture of the plate.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.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).The visual examination of the plate indicates a possible fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Fatigue fractures can occur due to a cyclic overloading.Possible contributing factors to the overload could be a not properly healed bone fracture and / or not adherence to the postoperative protocol (patient behavior).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 switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10073631
• Report Number: 0009613350-2020-00220
• Device Sequence Number: 2916819
• Product Code: HRS
• UDI-Device Identifier: 00889024292857
• UDI-Public: 00889024292857
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02264.015
• Device Lot Number: 3013015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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: 72