MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN TRILOGY SHELL; HIP PROSTHESIS

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that 8 patients were noted to have a radiolucent line less than 1mm thick and were non-progressive; no revisions took place.

Manufacturer Narrative

Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc2600993/.The devices were not returned for review as they remain implanted.The manufacturing documentation cannot be reviewed because item/lot information has not been received.The acetabular shell was an unknown trilogy shell with an extended offset liner in all cases.These devices were used in the treatment of a disease.No applicable patient history is provided.Compatibility of the devices is unknown.A complaint history search cannot be performed due to lack of information.With the information provided, a definitive root cause cannot be stated.

• Brand Name: UNKNOWN TRILOGY SHELL
• 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: 4917815
• MDR Text Key: 6056516
• Report Number: 1822565-2015-01191
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2015

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: 06/12/2015
• Initial Date FDA Received: 07/14/2015
• 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