MAUDE Adverse Event Report: ZIMMER GMBH NCB PERIPROS PROX FEMUR PLT ST; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: allofits alloclassic, shell with polar screw plug, uncemented, 48/gg item# 4263, lot# 2780712.Ncb, periprosthetic trochanter plate, left, narrow item# 0202263301, lot#3013727.G2.Report source: australia.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient has initial left total hip arthroplasty approximately 9 years ago.Subsequently, has been revised numerous times for multiple reasons including infection, stem fracture, periprosthetic bone fracture, and non-union over many years.Most recently, the patient has undergone the first stage of a two-stage revision with removal of all components approximately 7 months ago for infection and stem fracture.Product was returned and the plate was found to be fractured.Diligence is complete and additional information on the reported event is unavailable at this time.

• Brand Name: NCB PERIPROS PROX FEMUR PLT ST
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER 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: 18767988
• MDR Text Key: 336116845
• Report Number: 0009613350-2024-00055
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100111
• 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
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 0202263118
• Device Lot Number: 3025426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2020
• 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: 86 YR
• Patient Sex: Female