MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER CPT STEM; HIP PROSTHESIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Information was received via literature.Please reference literature at the following location: http://www.Boneandjoint.Org.Uk/content/jbjsbr/93-b/8/1045.Full.Pdf.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that one patient was revised due to pain secondary to massive femoral stem subsidence.

Manufacturer Narrative

No devices or photos were returned for review, as they remain implanted.Manufacturing documentation was not reviewed as item/lot numbers were not provided.The devices were used in treatment.Component compatibility is unknown.A complaint history search could not be performed due to the lack of lot numbers provided.With the information provided, a definitive root cause cannot be stated.

• Brand Name: UNKNOWN ZIMMER CPT 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: 5263561
• MDR Text Key: 32592958
• Report Number: 1822565-2015-02531
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

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: 11/06/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• 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