MAUDE Adverse Event Report: ZIMMER, INC. UNK ZIMMER EPOCH HIP STEM; HIP PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It is reported the patient was experiencing stem loosening due to the polyethylene component being worn and particles causing looseness from the top down.

Manufacturer Narrative

No devices or photos were rec'd; therefore the condition of the components is unk.These device are used for treatment.It could not be confirmed if the devices are an approved and compatible combination.Surgical notes were not provided.It is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Adherence to rehab protocol and relevant medical history are unk.A probable cause for the reported issue of loosening may be wear debris from the liner; however this could not be confirmed with the information provided.With the information provided, a definitive root cause cannot be determined.

• Brand Name: UNK ZIMMER EPOCH HIP STEM
• 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: 4877626
• MDR Text Key: 5867200
• Report Number: 1822565-2015-01009
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• 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: 05/27/2015
• 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
• Treatment: UNK ZIMMER POLY LINER, CATALOG #UNK, LOT #UNK
• Patient Outcome(s): Other