MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT STRAIGHT SHELL IMPACTOR

Catalog Number 01.00469.001

Device Problems Fitting Problem (2183); Material Deformation (2976)

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

Event Date 01/30/2015

Event Type  Other  

Event Description

It was reported that the surgeon was using an allofit straight shell impactor, during impaction of the cup, the handle deformed itself in such a way that the target device did not fit on the impactor.The impact to person affected is unk.

Manufacturer Narrative

The manufacturer did not receive devices, x-rays or other source documents for review.As no lot number was provided for the device, the device history record could not be reviewed.A cause for this specific event cannot be ascertained from the info provided.Should add'l info become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).

• Brand Name: ALLOFIT STRAIGHT SHELL IMPACTOR
• Type of Device: SHELL IMPACTOR
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p o box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 4575595
• MDR Text Key: 18893443
• Report Number: 9613350-2015-00281
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.00469.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other