MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 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	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.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 or Problem Description
It was reported that patient underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Investigation results were made available: additional d11, h2, h6.Correction: b3, b4, b5, h3, h10, g4, g7.Event description: it was reported that the product was implanted on (b)(6) 2018 and revised on (b)(6) 2019 due to ncb pp plate fracture.Review of received data: two undated x-rays have been provided.It can be seen that the patient has an existing hip prosthesis.The bone fracture occurred distal to the hip stem.According to the vancouver classification this is a type c fracture.A ncb pp distal femur plate was implanted with several screws.A breakage of the plate could not be seen on the x-rays.Devices analysis: the broken ncb pp plate was returned for investigation.The plate was broken 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 show also 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 plate.Review of product documentation: all involved devices are intended for treatment.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 are according to specification.Conclusion: 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 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 an 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
Investigation results are now available.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 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: 8662404
• Report Number: 0009613350-2019-00349
• Device Sequence Number: 2130757
• Product Code: HRS
• UDI-Device Identifier: 00889024292901
• UDI-Public: 00889024292901
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/29/2020

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: 02.02264.115
• Device Lot Number: 2939366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/29/2020
• 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 Age: 66 YR