MAUDE Adverse Event Report: ZIMMER UNKNOWN ZIMMER CPT HIP STEM; HIP PROSTHESIS

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that there have been issues with the 28mm trial cpt heads sticking on the stem implant.This had happened a couple of times resulting in the stem that was cemented in the patient becoming loose when trying to get the trial off the patient.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: UNKNOWN ZIMMER CPT HIP STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 3855463
• MDR Text Key: 21731125
• Report Number: 2648920-2014-00090
• Device Sequence Number: 1
• Product Code: JDJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: UNKNOWN 28MM TRIAL HEADS, CATALOG #UNK, LOT #UNK