MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 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	No Code Available (3191)
Date of Event	07/30/2020
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.Where lot numbers were received for the 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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to implant fracture.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Event description: it was reported that the patient received an implant on (b)(6) 2020 and revised on (b)(6) 2020 due to fractured ncb pp plate.Review of received data: no medical data relevant to the case has been received.Product evaluation: visual examination: 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 origins are located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are polished areas and some scratches, probably due to contact between the parts after the fracture.Additionally, next to the fracture, structured marks and polishing are visible which presumably could have derived from contact with the cerclage wires which was used for fracture fixation.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.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.Surgical technique: in the surgical technique it is described that ncb bone spacers may also be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire.(insert the adequate bone spacers into ncb screw holes before plate insertion).Conclusion: it was reported that the patient received an implant on (b)(6) 2020 and revised on (b)(6) 2020 due to fractured ncb pp plate.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.The raw material certificate of the plate was reviewed with no anomalies noted.The investigation did not identify a nonconformance 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).On the backside of the plate there are polished areas and structured marks visible where the cerclage wires were placed.In the surgical technique it is described that ncb bone spacers may also be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire.(insert the bone spacers into ncb screw holes before plate insertion).Not using spacers might have led to high bending stresses where the plate was in direct contact with the cerclage wire (lever arm situation).However, an exact root cause for the breakage of the ncb pp plate could not be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 15 HOLES, 317 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10390722
• Report Number: 0009613350-2020-00371
• Device Sequence Number: 11466571
• Product Code: HRS
• UDI-Device Identifier: 00889024292857
• UDI-Public: 00889024292857
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.02264.015
• Device Lot Number: 3003351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: 70 YR