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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/1297571.(b)(4).The device was not returned for review, therefore the conditions cannot be described.The device history record could not be reviewed as the item/lot number is unknown.The device was 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.

Event Description

It is reported there were two femoral side revisions due to progressive femoral subsidence secondary to pad separation.

• Brand Name: UNKNOWN ZIMMER 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: 5200376
• MDR Text Key: 30340165
• Report Number: 1822565-2015-02289
• 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
• Report Date: 10/07/2015

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: 10/07/2015
• Initial Date FDA Received: 11/04/2015
• 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