MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, RIGHT, 12 HOLES, 285 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2020
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
Note: the investigation identified that the actual product is: ncb femur plate ref: 02.03263.012; lot: 2959326.Event description: it was reported that the patient received an implant on (b)(6) 2020 and revised on (b)(6) 2020 due to implant fracture.Review of received data: product evaluation: visual examination: the visual examination shows that the femoral plate fractured.The fracture of the plate is located through the middle hole of the most distal three-hole-pattern.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.The fracture origin is located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are small polished areas and some scratches, most probably due to contact between the parts after the fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.The plate shows several slight scratches most probably originating from the implantation or revision surgery.The most proximal left screw hole on the trochanter plate is worn in such a way that only approximately 20% of the thread still exists.Around the rim of the screw hole coarse scratches can be seen.Wear can also be seen on the proximal part at the screw hole next to the fracture.Most of the thread is still intact.The trochanter plate is still well fixed to the ncb plate.Review of product documentation: device purpose: this device is 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.Ncr(s): 1 part was scrapped due to an error in the molding blank.It was detected during visual inspection of the surface of all parts (100%).Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the patient received an implant on (b)(6) 2020 and revised on (b)(6) 2020 due to implant fracture.Based on the investigation the reported event can be confirmed.The visual examination shows that the femur plate fractured, located through the middle hole of the most distal three-hole-pattern.The fracture surfaces point to a fatigue fracture.Two screw holes exhibit wear which indicates movements between the screw and the plate.Neither x-rays, operative notes or office visit notes were received; therefore patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.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 wrong patient behavior and / or a not properly healed bone fracture.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance 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.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, PROXIMAL, RIGHT, 12 HOLES, 285 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: 10612124
• Report Number: 0009613350-2020-00440
• Device Sequence Number: 1178730
• Product Code: HRS
• UDI-Device Identifier: 00889024292796
• UDI-Public: 00889024292796
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 01/27/2021

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: 02.03263.012
• Device Lot Number: 2959326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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 Weight: 58