MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date: detail of product: item number 0202263202.Item name ncb, periprosthetic trochanter plate, right, wide.Lot # 2976139.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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).(complaint linked to (b)(4)).
Event or Problem Description
It was reported that patient underwent revision surgery due to implant fracture probably caused by wrongful prebinding done by the surgeon.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Event description: the products have been initially implanted on (b)(6) 2019.The distal end of the ncb pp plate and screws migrated.Therefore, on (b)(6) 2019 the devices were extracted; the ncb pp plate was bent and reinserted into the patient on that same surgery.That bent lead to fracture of the product and the patient was revised on (b)(6) 2019 due to implant fracture.(b)(4) created for migration; implant bent and reinserted on (b)(6) 2019 (reported in 0009613350-2020¿00171-1).(b)(4) created for revision on sep 3, 2019 due to implant fracture (this report).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.Product evaluation: visual examination: the fracture of the ncb pp 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 origins are located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are several polished areas and some scratches, probably due to contact between the parts after the fracture.The trochanteric plate is slightly loose on the ncb pp plate.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.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Instruction for use (ifu): in the ifu the following is listed in the section warnings: - do not reuse.This device is single use only.- reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.Surgical technique sap: surgical technique sap doc no.06.02013.012 rev.04: be aware that bending the plate may decrease its fatigue strength.Furthermore, the locking mechanism of the ncb hole may be damaged and, therefore, may no longer function.Do not use a hole that has been altered by contouring for locking.If the plate is bent, the mis guide cannot be used.Do not bend the ncb periprosthetic trochanter plate.Conclusion: the products have been initially implanted on (b)(6) 2019.The distal end of the ncb pp plate and screws migrated.Therefore, on (b)(6) 2019 the devices were extracted; the ncb pp plate was bent and reinserted into the patient on that same surgery.That bent lead to fracture of the product and the patient was revised on (b)(6) 2019 due to implant fracture.The ncb pp plate was in vivo for approx.6 months.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 nonconformance or a complaint out of box (coob).Bending of a ncb pp plate is mentioned in the surgical technique.It is stated that bending the plate may decrease its fatigue strength.Furthermore, the locking mechanism of the ncb hole may be damaged and, therefore, may no longer function.The visual examination of the plate indicates that no material defects that could have triggered the fracture could be detected.The material analysis shows an indication for a fatigue 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, the review of the ifu says do not reuse.This device is single-use only.Reuse of a single use device can be considered as an off-label use.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).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 18 HOLES, 363 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9933239
• Report Number: 0009613350-2020-00176
• Device Sequence Number: 16310064
• Product Code: HRS
• UDI-Device Identifier: 00889024292710
• UDI-Public: 00889024292710
• 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
• Report Date (Section B): 08/24/2020

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: 02.02263.018
• Device Lot Number: 2963779
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/19/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• 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: REFER TO H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention