MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 21 HOLES, 393 MM; TRAUMA PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Malunion of Bone (4529)

Event Date 08/28/2022

Event Type  Injury  

Event Description

It was reported that patient underwent right knee revision surgery due to a non union event in unknown time frame post-op.During surgery it was discovered that the periprosthetic femur plate was bent/fractured.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.A review of the provided photographs confirms the plate has fractured.Lot identification is necessary for review of device history record lot identification was not provided.Device is used for treatment.Medical records were not provided.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: NCB®, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 21 HOLES, 393 MM
• 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: 15367781
• MDR Text Key: 299357651
• Report Number: 0009613350-2022-00444
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024297593
• UDI-Public: (01)00889024297593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• 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: 0203264021
• 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: 10/06/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 99 KG