MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 12 HOLES, 278 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	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did receive per and x-rays for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 implant fracture.
Event or Problem Description
Investigation has been completed.
Additional Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the product was implanted on (b)(6) 2020 and revised on (b)(6) 2020 due to implant fracture.The ncb plate had to be bent with the special bending device.The event occurred on (b)(6) 2020.Review of received data: x-rays: the x-ray review was done by a radiologist.There is a transversely oriented fracture in the proximal portion of the position metallic sideplate with mild to moderate displacement of the distal fracture component, likely posterolaterally.No other fractures are seen within the hardware.No periprosthetic lucencies are identified.Along the lateral margin of the distal diaphysis of the femur, is a periprosthetic cortical/subcortical fracture which is located adjacent to the proximal tip of the femoral stem.There is some periosteal reaction noted along the medial cortex of the femur at the site of the bone fracture which could potentially represent increased stress reaction at the site or findings related to prior injury.Product evaluation: visual examination: the broken ncb pp plate was returned for investigation.The plate was broken into two fragments.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 bone-facing side the plate has several polished spots.On the fracture surfaces there are polished areas, some scratches and some wear, probably due to contact between the parts after the fracture.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.Conclusion: it was reported that the product was implanted on (b)(6) 2020 and revised on (b)(6) 2020 due to implant fracture.The ncb plate had to be bent with the special bending device.The event occurred on (b)(6) 2020.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.Therefore, the investigation results did not identify a non-conformance or a complaint out of box (coob).The complaint history search identified no additional complaints for the same reference and lot number combination.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).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 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, 12 HOLES, 278 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: 10598822
• Report Number: 0009613350-2020-00430
• Device Sequence Number: 16958595
• Product Code: HRS
• UDI-Device Identifier: 00889024292840
• UDI-Public: 00889024292840
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/21/2021

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: 02.02264.012
• Device Lot Number: 2906815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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