MAUDE Adverse Event Report: ZIMMER TRABECULAR METAL TECHNOLOGY TRABECULAR METAL REVISION SHELL, 60MM; TM REVISION SHELL

Catalog Number 02-210-00603

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Toxicity (2333); Reaction (2414)

Event Date 09/04/2013

Event Type  Injury  

Event Description

The patient is pursuing a product liability claim arising out of the use of the acetabular revision shell.It is reported by the patient's counsel that the patient received a tha on (b)(6) 2005 and was revised using the acetabular revision shell on (b)(6) 2012 due to loosening of the shell/cup.It was also reported that the patient had complications with metallosis, but the acetabular revision shell is not indicated for use with a metal on metal insert.

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 additional information be obtained to further this investigation, this report shall be updated.

• Brand Name: TRABECULAR METAL REVISION SHELL, 60MM
• Type of Device: TM REVISION SHELL
• Manufacturer (Section D): ZIMMER TRABECULAR METAL TECHNOLOGY; 10 pomeroy rd.; parsippany NJ 07054
• Manufacturer Contact: anand singh ; 10 pomeroy rd.; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 4698695
• MDR Text Key: 5677961
• Report Number: 3005751028-2015-00029
• Device Sequence Number: 1
• Product Code: KWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: LETTER T
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2009
• Device Catalogue Number: 02-210-00603
• Device Lot Number: 56465216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2004
• 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
• Patient Age: 30 YR