MAUDE Adverse Event Report: ZIMMER INC UNKNOWN M/L TAPER EXTENDED OFFSET STEM; KWZ

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.(b)(4).Concomitant medical products: catalog #unk, unknown zimmer femoral head, lot #unk.Please reference literature at the following location: http://www.Bjj.Boneandjoint.Org.Uk/content/97-b/8/1024.Long this report will be amended when our investigation is complete.

Event Description

It is reported that during revision surgery on a (b)(6) female, corrosion was noted at the head-neck junction for metal-on-highly cross linked polyethylene, 53 months after total hip arthroplasty.

Manufacturer Narrative

The devices were not returned for review, therefore their conditions cannot be described.The device history records could not be reviewed as the item/lot numbers are unknown.The devices were used in treatment.No applicable patient history is available for review.Compatibility of the devices is unknown.A complaint history review could not be performed with the lack of identifying product information.With the information provided, a definitive root cause cannot be stated.

• Brand Name: UNKNOWN M/L TAPER EXTENDED OFFSET STEM
• Type of Device: KWZ
• 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: 5138209
• MDR Text Key: 27899017
• Report Number: 1822565-2015-02098
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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: 10/19/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR