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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature: (b)(4).Please reference literature at the following location: (b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to extensive osteolysis and migration of the implant.

Manufacturer Narrative

No device or photos were provided therefore; the condition of the component is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.The reported device is used for treatment.Complaint history search and compatibility cannot be reviewed since the part and lot numbers are unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN HARRIS/GALANTE FEMORAL 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: 5408434
• MDR Text Key: 37418397
• Report Number: 1822565-2016-00204
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• 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: 01/06/2016

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: 01/06/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/12/2016
• 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
• Patient Age: 69 YR