MAUDE Adverse Event Report: ZIMMER TMT TM CRUCIATE RETAINING MONOBLOCK TIBIA; TM MONOBLOCK TIBIA

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 12/03/2014

Event Type  Injury  

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.

Event Description

The patient is pursuing a product liability claim arising out of the use of trabecular metal monoblock tibial and femoral component implants.It is reported by the patient's counsel that the patient received both implants on (b)(6) 2011 and was revised on (b)(6) 2014 due to loosening.Note that the femoral component is of zimmer biomet (b)(4) design control and the tibial component is of zimmer biomet (b)(4) design control.

• Brand Name: TM CRUCIATE RETAINING MONOBLOCK TIBIA
• Type of Device: TM MONOBLOCK TIBIA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: anand singh ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 5293304
• MDR Text Key: 33396329
• Report Number: 3005751028-2015-00169
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00588604710
• Device Lot Number: 61833834
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR