MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Insufficient Information (4580)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: ncb screw 5.0 l = 32; item# : 0203150032; lot# : unknown.Ncb screw 5.0 l = 40; item# : 0203150040; lot# : unknown.Ncb screw 5.0 l = 42; item# : 0203150042; lot# : unknown.Ncb screw 5.0 l = 44; item# : 0203150044; lot# : unknown.Ncb screw 5.0 l = 50; item# : 0203150050; lot# : unknown.Ncb scr d 4.0 self-tapping 38; item# : 0203155038; lot# : unknown.Ncb scr d 4.0 self-tapping 40; item# : 0203155040; lot# : unknown.Ncb scr d 4.0 self-tapping 42; item# : 0203155042; lot# : unknown.Therapy date: (b)(6) 2021.The manufacturer received x-rays and other source documents 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 Description

Patient was implanted on right side and was revised due to plate fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient was implanted with a ncb plate on (b)(6) 2021 and was revised on (b)(6) 2021 due to implant fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: one image with two views of the right femur has been received.The right radiograph is undated, the left radiograph is labeled (b)(6) 2021.The following analysis has been performed by a radiologist.Two views of the right femur demonstrate a right total hip arthroplasty with cement fixation of the acetabular cup and two proximal cerclage wires.On the first image, there is a lateral plate and screw fixation device involving the femur.Displaced transverse fracture involving proximal femoral diaphysis and plate and screw fixation device seen on the first image along with nondisplaced transverse fracture involving the proximal femoral diaphysis on the second image with surgical skin staples.Plate appears to be repaired on the second image.Overall fit and alignment of the implants is appropriate.No signs of loosening, wear, radiolucency.No additional medical data has been provided due to patient privacy policy.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.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 could no be performed due to missing product identification.Conclusion: it was reported that the patient was implanted with a ncb plate on (b)(6) 2021 and was revised on (b)(6) 2021 due to implant fracture.Based on the received radiographs the reported event can be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the information provided, we are unable to provide further analysis of the complaint reported, or draw any definitive conclusions as to the root cause of the reported issue.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).

Event Description

No change to previously reported event.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
• Type of Device: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12552512
• MDR Text Key: 273982761
• Report Number: 0009613350-2021-00503
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297524
• UDI-Public: 00889024297524
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03263.115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female