MAUDE Adverse Event Report: ZIMMER TRABECULAR METAL TECHNOLOGY (TMT) CERAMIN ON CERAMIC HEDROCEL ONE PIECE PRIMA; HEDROCEL ACETABULAR CUP WITH CERAMIC

Catalog Number 02-272-28581

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that a patient, who was part of a clinical trial ((b)(6)), was revised due a disassociation of the ceramic liner.Normally, the adverse event is reported through the annual report from the study; however, as of this date, the study is officially closed.The study number is (b)(4).

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should add'l info be obtained to further this investigation, this report shall be updated.

• Brand Name: CERAMIN ON CERAMIC HEDROCEL ONE PIECE PRIMA
• Type of Device: HEDROCEL ACETABULAR CUP WITH CERAMIC
• Manufacturer (Section D): ZIMMER TRABECULAR METAL TECHNOLOGY (TMT); 10 pomeroy rd.; parsippany NJ 07054
• Manufacturer Contact: bill hara ; 10 pomeroy rd.; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 3621491
• MDR Text Key: 16912103
• Report Number: 3005751028-2014-00013
• Device Sequence Number: 1
• Product Code: LPF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2004
• Device Catalogue Number: 02-272-28581
• Device Lot Number: 99271471-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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): Required Intervention