MAUDE Adverse Event Report: ZIMMER, INC. CABLE-READY CABLE CERCLAGE WITH CRIMP; TRAUMA PROSTHESIS

Catalog Number 00223200418

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/24/2013

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to a periprosthetic fracture.

Manufacturer Narrative

This report is being amended to reflect changes.Device history records were reviewed for lots 61723287, 61912038, & 61912036 with no deviations or anomalies identified that would have contributed to the reported event.Receiving and inspections reports were reviewed for all material lots for complaint parts and revealed all devices that were accepted, completed, and sent to inventory met specifications.The three cables were not returned for review; therefore, the exact condition of the components is unknown.This device is used for treatment.Based on the order running complete, it is believed the part was conforming when it left zimmer biomet.It was reported that the patient experienced a periprosthetic fracture, but operative notes were not received.The exact cause of the fracture and the condition of the implants cannot be determined.A definitive root cause for the fracture cannot be determined with the information provided.

• Brand Name: CABLE-READY CABLE CERCLAGE WITH CRIMP
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5737751
• MDR Text Key: 47825928
• Report Number: 0001822565-2016-02119
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 00223200418
• Device Lot Number: 61912036
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2011
• 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: 54 YR