MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 9 HOLES, 238 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	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that patient underwent revision due to implant fracture.
Additional Manufacturer Narrative
Additional information which was received on dec 11, 2019: a cause for this specific event cannot be ascertained from the information provided.Should additional information become available 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 on right side and underwent revision due to implant fracture.
Additional Manufacturer Narrative
Event summary: it was reported that product was implanted on (b)(6) 2019 and underwent revision on (b)(6) 2019 due to implant fracture.Review of received data in total 34 x-ray were received.The x-rays are dated between (b)(6) 2019 and (b)(6) 2019.(b)(6) 2019 : patient has an existing knee prosthesis and 3 screws in the hip on the right and a nailing system on the left.(b)(6) 2019 : periprosthetic femur fracture on the right around the existing knee prosthesis.(b)(6) 2019 : implantation of a ncb pp plate with several screws and 2 cerclage wires.(b)(6) 2019 : breakage of the ncb pp plate visible (fifth screw hole, seen from proximal).(b)(6) 2019 : implantation of a new ncb pp plate.Surgical report of implantation (b)(6) 2019 : diagnosis: dislocated multi-fragmentary periprosthetic fracture of the distal femur shaft on the right, existing innex sc prosthesis (implanted in 2015) several heart attacks, acvb, stent implantation, as medication diabetes mellitus.Pavk.Impending skin perforation.Surgery: difficult reposition of the fracture.Implantation of a 9 hole ncb pp plate with several screws and cerclage wires.Surgical report of removal (b)(6) 2019: diagnosis: pseudarthrosis right femur and fracture of the ncb pp plate as medication.Cardiac history.Surgery: removal of the broken ncb pp plate and sub components.The bone fracture is not completely healed (consolidated).A pseudoarthrosis region can be seen.Cleaning and implantation of a new 9 hole ncb pp plate with several screws and cerclage wires.Devices analysis.Visual examination: the broken ncb pp plate and screws have been returned for investigation.The visual examination shows that the fracture of the plate is located through the middle of the fifth screw hole (counted from proximal).On the fracture surfaces, some 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 small polished areas, some scratches and some wear and deformation, probably due to contact between the parts/screw after the fracture.On the bone-facing side, just above the plate¿s eights screw hole there is an area that shows a mixture of smeared material and slight wear.This could possibly originate from contact with a cerclage wire.The caps and screws shows some instrument damage, most probably from implantation/revision.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 are according to specification.Conclusion summary.It was reported that the patient had a revision surgery due to a ncb pp plate fracture.The plate was in vivo for approximately 5.5 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.Fatigue fractures occur due to a cyclic overloading.Possible contributing factors to the overload could be wrong patient behaviour, unfavorable load distribution due to the cerlage placed directly between bone and plate and / or a not properly healed bone fracture.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, DISTAL, RIGHT, 9 HOLES, 238 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: 9414985
• Report Number: 0009613350-2019-00765
• Device Sequence Number: 1725397
• Product Code: HRS
• UDI-Device Identifier: 00889024292833
• UDI-Public: 00889024292833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/06/2020

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: 02.02264.009
• Device Lot Number: 2937816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 04/03/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/20/2019; 04/06/2020
• 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: 68 YR