MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-rays and other documents which will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not 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.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 implant fracture.
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Additional information which was received on jan 03, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Additional Manufacturer Narrative
Trend analysis: no trend has been indentified.Event description: it was reported that a patient was implanted with a ncb pp plate on (b)(6) 2019 due to a periprosthetic fracture.Patient underwent a revision surgery on (b)(6) 2019 due to implant fracture.Review of received data: this review of the x-ray was performed through the mmi portal for radiologic imaging, surveillance, and management.Opinions rendered in this case are the opinions of the reviewing radiologist and are based on the provided images: two views of the right hip demonstrate a right total hip arthroplasty in place.There is a lateral plate and screw fixation with multiple cerclage wires seen.On image one, the plate is intact with evidence of an oblique fracture involving the proximal to mid diaphysis of the femur just distal to the femoral component.On image two and three, there is a fracture of the plate at the level of the tip of the femoral component and fracture line along with a screw which has backed out.Impressions of the x-rays: right total hip arthroplasty with lateral side plate and screw fixation with multiple cerclage wires which eventually fractures at the level of the tip of the femoral component as well as a proximal to mid femoral diaphysis fracture along with backing out of a screw at the same level.No other medical data or any other case-relevant documents were received.Devices analysis: the ncb pp plate was returned for investigation.The plate is fractured into two parts.The fracture of the plate is located through a three-hole pattern.On the fracture surfaces, slight beach lines are visible which point to a fatigue fracture.The fracture surfaces show also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Further, no considerable deteriorations, deformations or imperfections can be seen.Based on this visual examination the reported event can be confirmed.Review of product documentation: this device is intended for treatment.All involved devices are intended for treatment.The compatibility check could not be performed as only one product has been reported.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: 03-jun-2020.The review showed that the material met all the predefined specifications for the material.The material was analyzed internally on 11-june-2017 previous to the production.Conclusion summary: it was reported that the patient had a revision surgery due to a ncb pp plate fracture.The plate was in vivo for approximately 3 months.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 x-rays showed a right total hip arthroplasty with the ncb pp and screw fixation with multiple cerclage wires which fractured at the level of the tip of the femoral component as well as a proximal to mid femoral diaphysis fracture along with backing out of a screw at the same level.The ncb pp plate was returned for investigation and is fractured into two parts.The visual examination of the plate indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Fatigue fractures could occur due to a cyclic overloading.A possible contributing factor to the overload could be a not properly healed bone fracture.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
Investigation completed.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM
• Common Device Name: NCB, PERIPROSTHETIC FEMUR PLATE
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9493815
• Report Number: 0009613350-2019-00810
• Device Sequence Number: 1542568
• Product Code: HRS
• UDI-Device Identifier: 00889024292697
• UDI-Public: 00889024292697
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 02.02263.012
• Device Lot Number: 2930347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 06/03/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/14/2020; 06/11/2020
• 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: 71