MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN NCB DISTAL FEMUR PLATE; TRAUMA PROSTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign- norway.Concomitant associated products: item number: unknown, item name: unknown ncb screw, lot number: unknown.Item number: unknown, item name: unknown ncb screw, lot number: unknown.Item number: unknown, item name: unknown ncb screw, lot number: unknown.Multiple mdr reports were filed for this event, please see associated report: 0009613350-2022-00487, 0009613350-2022-00488, 0009613350-2022-00490.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that after implementation of unknown distal femoral plate, the screws migrated causing the plate to penetrate the patients skin leading to infection.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Devices are used for treatment.Complaint history review cannot be performed without product identification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the distal left femur demonstrate a left total knee arthroplasty and lateral plate and screw fixation device with an oblique fracture involving the distal diaphysis of the femur.Vascular calcifications.Loosening of the distal femoral plate also seen.The lateral femoral plate has withdrawn with screws seen within the soft tissues.Oblique fracture of the distal femur suggests trauma.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN NCB DISTAL FEMUR PLATE
• Type of Device: TRAUMA PROSTHESIS
• 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: 15468603
• MDR Text Key: 300419774
• Report Number: 0009613350-2022-00486
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN NCB DISTAL FEMUR PLATE
• 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: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female