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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Information was received via published literature.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that 13 hips had decreased density of the proximal medial cortex and were classified as grade iii, leading to the complete cancellization of the medial neck.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the devices is unknown.The part and lot number of the products are unknown; therefore the device history records, complaint history could not be reviewed.The reported devices are used for treatment.It could not be confirmed if the devices were used in an approved and compatible combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown.A definitive 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: 5470995
• MDR Text Key: 39379550
• Report Number: 1822565-2016-00441
• 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: 03/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other