MAUDE Adverse Event Report: ZIMMER INC UNKNOWN HARRIS/GALANTE HIP 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.Event problem codes: (b)(4).Please reference literature at the following location: http://www.Arthroplastyjournal.Org/article/s0883-5403(07)80028-3/pdf no devices or photos were received; therefore the condition of the components is unknown.These devices are used for treatment.It was reported in the journal article "cementless total hip arthroplasty using a porous-coated prosthesis for bone ingrowth fixation" that 58 hips had grade 0-2 changes and the remaining had 3-4 grade changes.It was also reported that the calcar showed changes of osteoporosis, rounding off and/or lesion in the calcar region which indicates probable osteolysis.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.The complaint may be revised upon return of substantial information.

Event Description

It is reported that sixty-nine hips had grade 0-iv changes when assessed for stress shielding.

• Brand Name: UNKNOWN HARRIS/GALANTE HIP 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: 5471637
• MDR Text Key: 39415448
• Report Number: 1822565-2016-00486
• 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: 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
• 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