MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER VERSYS HEAD; HIP PROSTHESIS

Device Problem Compatibility Problem (2960)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported that a patient was implanted with a muller protasul s30 stem with a versys head, which is not an approved or cleared combination of product.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

No product is returned for review.This complaint does not allege that the devices failed to meet specification.Insufficient information has been provided to perform a device history records review.However, a complaint of this nature would not benefit from a review of manufacturing documentation.These devices were used for the treatment of a disease.No specific patient history is available.A complaint search of the manufacturing lot cannot be performed without receipt of the device lot number.This combination of products is considered an off-label use of the device as stated in the ifu.Zimmer has not tested the compatibility of this combination of devices.The ifu states, "only authorized combinations should be used.To determine whether these devices have been authorized for use in a proposed combination, please contact your zimmer sales representative or visit the zimmer website: www.Productcompatibility.Zimmer.Com." the cause of the described event is a failure to follow instructions.

• Brand Name: UNKNOWN ZIMMER VERSYS HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4898115
• MDR Text Key: 6834830
• Report Number: 1822565-2015-01095
• Device Sequence Number: 1
• Product Code: JDG
• 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,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• 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
• Patient Sequence Number: 1
• Treatment: CATALOG #: UNK, LOT #: UNK, MANUFACTURED BY; ZIMMER (B)(4).
• Patient Outcome(s): Other