MAUDE Adverse Event Report: ZIMMER INC UNKNOWN HARRIS/GALANTE STEM; HIP PROSTHESIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Information was received via journal article.(b)(4).Other device used: catalog #unk, unknown harris/galante porous acetabular shell, lot #unk.This report will be amended when our investigation is complete.

Event Description

It is reported that two patients participated in high-impact activities developed endosteal lysis.One of whom awaits revision arthroplasty because of lysis and subsidence of the prosthesis.

Manufacturer Narrative

Since the part and lot numbers of the components are unknown, a device history record review could not be completed.Since the product was not returned their condition is unknown.These devices are used for treatment.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.The hgp femoral prosthesis package insert states that risk of mechanical fracture or loosening of the femoral component increases significantly with excessive weight and activity of the patient.It is likely that the patient activity levels caused or contributed to the reported loosening.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN HARRIS/GALANTE STEM
• 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: 5413599
• MDR Text Key: 37567052
• Report Number: 1822565-2016-00217
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention