MAUDE Adverse Event Report: ZIMMER TMT TM MONOBLOCK TIBIA

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that the surgeon revised the polyethylene on the tm monoblock tibia due to a loose screw.The patient reported that he had stepped out of his truck and felt something and then couldn't bend his knee.The patient was implanted with a tm monoblock tibia on (b)(6) 2013 and revised due to infection sometime in (b)(6) 2014.

Manufacturer Narrative

Investigation is in progress.

Manufacturer Narrative

This complaint initially when received referred to a "tm monoblock tibia" being implanted on (b)(6) 2013 and revised in (b)(6) 2014.However, after review of the zimmer biomet (b)(4) complaints, it was found that the tibia that was actually implanted was unknown, except that it was a size 3 and had a modular poly articulating surface.The poly articulating surface was revised.Note that zimmer biomet tmt does not manufacture a modular tibial component; therefore, this component is not within zimmer biomet (b)(4) design control.Zimmer biomet (b)(4) will transfer this information to zimmer biomet (b)(4) for further evaluation.

Event Description

It was reported that the surgeon revised the polyethylene on the tm monoblock tibia due to a loose screw.The patient reported that he had stepped out of his truck and felt something and then couldn't bend his knee.The patient was implanted with a tm monoblock tibia on (b)(6) 2013 and revised due to infection sometime in (b)(6) 2014.

Manufacturer Narrative

Additional information received on 7/21/2016: part number 00588604514, lot number 62047575.

• Brand Name: TM 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 3722
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054-3722 ; 9735760032
• MDR Report Key: 4862993
• MDR Text Key: 5866964
• Report Number: 3005751028-2015-00082
• 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: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00588604514
• Device Lot Number: 62047575
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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: 51 YR