MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN RIGHT 11MM DIAMETER 42CM LENGTH ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/28/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4). Report source: foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient was revised due to bone fracture. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: GREATER TROCHANTER FEMORAL NAIL - GREEN RIGHT 11MM DIAMETER 42CM LENGTH
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12506560
• Report Number: 0001822565-2021-02725
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47249242011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• 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
• Removal/Correction Number: N/A
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Outcome(s): Hospitalization; Required Intervention