MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 03/17/2021

Event Type  Injury  

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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the ncb plate had fractured.Surgeon used another suppliers screws.It is not known when the event occurred.No further information available.

Event Description

Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.1.Event description: it was reported that the ncb plate was fractured on (b)(6) 2021.Surgeon used screws from an another supplier.Harm: s3 - instability, moderate.Hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.3.Product evaluation: visual examination: the fractured ncb pp plate and several screws were returned for investigation.The plate is fractured into two parts.The fracture of the plate is located through a screw hole.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.The fracture surfaces shows also small polished areas and some scratches, most probably due to contact between the parts after the fracture.The visual examination of the returned screws showed that zimmer biomet is not the legal manufacturer of those screws.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was not approved by zimmer biomet.The visual examination of the returned screws showed that zimmer biomet is not the legal manufacturer of those screws.This can be considered as an off label use.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.5.Conclusion: it was reported that the ncb plate was fractured on (b)(6) 2021.Surgeon used screws from an another supplier.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 under certain light condition a 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).In addition, the reported event also mentions that the surgeon used screws from another manufacturer.The visual examination confirmed that zimmer biomet is not the legal manufacturer of the returned screws.Therefore, this can be considered as an off label use.If and to what extend the above mentioned factors may have contributed to the course of event remains unknown.Therefore, 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).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM
• Type of Device: 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: 11573785
• MDR Text Key: 243776218
• Report Number: 0009613350-2021-00149
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024292697
• UDI-Public: 00889024292697
• Combination Product (y/n): N
• PMA/PMN Number: K100111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02263.012
• Device Lot Number: 3028843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization