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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Osteolysis (2377)

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/1548268.No device or photos were received, therefore the condition of the component is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.This device is 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.In the journal article, it was noted that the patient had diffuse osteolysis with generalized expansion of the intramedullary canal.Product history search cannot be completed since the part and lot numbers are unknown.Relevant medical history and adherence to the rehabilitation protocol are unknown.A definite root cause cannot be determined with the information provided.

Event Description

It is reported that a (b)(6) male received insertion of harris galante porous coated total hip prosthesis without cement.The prosthesis has subsided and there is diffuse cortical osteolysis.

• Brand Name: UNKNOWN HARRIS/GALANTE FEMORAL STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6031605
• MDR Text Key: 57550441
• Report Number: 0001822565-2016-03710
• 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: Other
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR