MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER PLATE AND SCREW ASSEMBLY; JDP

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient's femoral rod bent fracturing his femur and breaking the screws.

Manufacturer Narrative

The device was not returned for evaluation; therefore, no physical evaluation could be conducted.Device history records and complaint history review could not be completed due to lack of product identification; the lot number required for retrieval was unavailable.This device is used for treatment.The investigation could not identify or verify any evidence of product contribution to the reported problem.This complaint could not be confirmed.Based on the available information, root cause could not be determined.

• Brand Name: UNKNOWN ZIMMER PLATE AND SCREW ASSEMBLY
• Type of Device: JDP
• 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: 5630858
• MDR Text Key: 44383564
• Report Number: 0001822565-2016-01430
• Device Sequence Number: 1
• Product Code: JDP
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 87