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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-ray and documents for review.The manufacturer received the device for investigation.Where lot numbers were received for the explanted 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 or Problem Description
Patient was implanted on the right side and underwent revision surgery due to fractured ncb plate.
Event or Problem Description
Please refer to report 0009613350 - 2018 - 01245.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: plate breakage event description: it was reported that the patient fell and was revised due to implant breakage.Review of received data: only 1 x-ray picture was provided.The quality of the x-ray is poor.However, the breakage of the ncb pp plate can be seen around the distal part of the existing hip stem.Device analysis: visual examination: the broken ncb pp plate, 14 ncb screws (of them is broken), 13 locking caps and 1 cable button were available for material analysis.A visual examination was performed.The fracture of the plate is located through two bore holes.One bore hole is affected in a three hole pattern and the other broken bore hole is the little hole of the connection area for the targeting device (mis interface).Next to the broken little hole, a crack can be seen.The fracture surface shows signs of overload fracture.The plate shows also several scratches on their outer surface.The sub components do not show any abnormality or deformation.Based on this visual examination the reported event can be confirmed.Review of product documentation: all involved devices are intended for treatment.The product combination was approved by zimmer biomet, as per surgical technique.Conclusion: it was reported that the ncb pp plate was implanted on an unknown date and revised on (b)(6) 2018 due to implant fracture.The in vivo time of the plate is unknown.The quality records of the ncb pp plate show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The received x-ray picture confirms the breakage of the ncb pp plate.The visual examination of the plate indicates that no material defects that could have triggered the fracture could be detected.It can be assumed that the plate was broken during the fall of the patient.As the ncb pp plate shows signs of overload fracture, high forces must be applied to the ncb pp plate during the fall of the patient.It can also be assumed that the breakage of the screw occurred during the plate breakage.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the available information and performed investigation, an exact root cause for the plate breakage could not be determined.However, the patient fall can be considered the most probable cause for the reported fracture.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 PLATE, PROXIMAL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8173582
• Report Number: 0009613350-2018-01245
• Device Sequence Number: 1747460
• Product Code: HRS
• UDI-Device Identifier: 00889024292710
• UDI-Public: 00889024292710
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 02.02263.018
• Device Lot Number: 2869414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 07/11/2019
• 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