MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

Device Problems Fracture (1260); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 12/09/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to implant frature of ncb proximal tibia plate.

Manufacturer Narrative

Therapy date: (b)(6) 2021.The manufacturer received x-rays and surgery reports and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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).

Manufacturer Narrative

Therapy date: (b)(6) 2021.The manufacturer received x-rays and surgery reports and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 a revision surgery was performed due to implant fracture of ncb proximal tibia plate.

Event Description

Investigation results are now available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Investigation results are available 1.Event description: it was reported that the patient was revised due to a broken ncb proximal tibia plate.Harm: s3 - bone malunion/non-union, resulting in revision or other interventions hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.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: the provided x-rays were reviewed by a health care professional; however they were not sent for further evaluation as the surgical reports provided sufficient findings.Surgical report: review of the surgical report dated (b)(6) 2021 found the patient was implanted with a ncb proximal periprosthetic fracture plate for a femur fracture.There were no noted abnormalities during the procedure.Review of the surgical report dated (b)(6) 2021 found that the patient was being revised due to a fracture of the plate and the absence of healing.One screw from the initial plate was firmly in the femur and was left in vivo during the revision.A new plate was placed after fracture reduction of the bone.3.Product evaluation: visual examination: the broken ncb pp plate and sub components were returned for investigation.The plate was broken into two fragments.The fracture of the plate is located through the middle screw hole of a three hole pattern.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.Several scratches are visible on the surface of the non-bone-facing side of the plate.In addition, a broken screw head is returned.The other screws and locking caps do not show any damages or deformations.4.Review of product documentation: device purpose: all involved devices are 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.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.5.Conclusion: it was reported that the patient had a revision surgery due to a ncb pp plate fracture.The plate was in vivo for 1.5 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 visual examination of the plate indicates a fatigue fracture.Microscopically, 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 if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet's reference for this event is: (b)(4).

• Brand Name: NCB®, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 15 HOLES, 324 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
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13189433
• MDR Text Key: 285160678
• Report Number: 0009613350-2022-00015
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.03263.015
• Device Lot Number: 3061907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 89 KG