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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://jbjs.Org/content/75/4/554.Article-info.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that heterotopic ossification developed in 88 hips.The ossification led to an excision in 3 of the 88 hips.

Manufacturer Narrative

No device or photo was 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 the treatment.Complaint history search and compatibility cannot be reviewed since the part and lot numbers are unknown.Relevant medical history and adherence to rehabilitation protocol are unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN HARRIS/GALANTE IMPLANT
• 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: 5460615
• MDR Text Key: 39032663
• Report Number: 1822565-2016-00370
• 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: 02/02/2016

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: 02/02/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• 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): Other