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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported that the pt is alleging harm caused by the device, however the nature of the harm is unk at this time.

Manufacturer Narrative

Surgical notes were not provided.X-rays were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Pt factors that may affect the performance of the components such as age, bone quality, height/weight, type of activity (low impact vs.High impact), and relevant medical history are unk.Adherence to rehabilitation protocol is unk.Cause cannot be definitively determined.No devices or photos were received; therefore, the condition of the components is unk.Review of the device history records was not possible as the product and/or lot numbers required for retrieval were unavailable.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available info, the need for corrective action is not indicated.Should additional substantive info be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

• Brand Name: UNKNOWN ZIMMER HIP
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4797717
• MDR Text Key: 20362674
• Report Number: 1822565-2015-00765
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• 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?: No
• Date Manufacturer Received: 04/21/2015
• 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