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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer dud not receive x-rays or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.As no lot number was provided, the device history records could not be reviewed.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.(b)(4).
Event or Problem Description
Patient was implanted with a ncb plate and underwent revision due to implant fracture.
Additional Manufacturer Narrative
Additional information which was received on june 18, 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: b3, d10.Corrections: b4, g4, g7, h10.The manufacturer received email communication for the event date, surgical technique utilized and the device 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).
Event or Problem Description
Patient was implanted with a ncb plate and underwent revision due to implant fracture.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the product was implanted on (b)(6) 2019 and explanted on (b)(6) 2020 due to broken ncb pp plate.The implant got fractured during a normal load while taking a walk.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 broken ncb pp plate, ncb screws and locking caps were returned for investigation.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 origins are located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are several polished areas.The polished areas are probably due to contact between the parts after the fracture.There are also several scratches visible on both sides of the plate.In addition, one ncb screw was returned with a broken screw head.No other damages or any deformations can be seen.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.The raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the product was implanted on (b)(6) 2019 and explanted on (b)(6) 2020 due to broken ncb pp plate.The implant got fractured during a normal load while taking a walk.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.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 gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 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: 9966423
• Report Number: 0009613350-2020-00196
• Device Sequence Number: 19792225
• Product Code: HRS
• UDI-Device Identifier: 00889024297524
• UDI-Public: 00889024297524
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2020

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: 02.03263.115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 06/18/2020; 09/10/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/10/2020; 09/14/2020
• 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