MAUDE Adverse Event Report: ZIMMER TMT TM CR MONOBLOCK TIBIAL COMPONENT; TM MONOBLOCK TIBIA

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

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 contacted zimmer biomet inquiring if their knee implants were recalled.The patient is experiencing radiating bilateral knee pain and has described it as "pain on the bottom of both their knees and the pain runs up both thighs." the patient received two tm monoblock tibia components on (b)(6) 2012 (one in each knee); however, it is unknown which knee was implanted with the specific lot of tm monoblock tibia.As of this notification, the patient has not been revised.

Manufacturer Narrative

Patient is status post bilateral knee tka.It is unknown which specific femoral component is mated with which tm monoblock tibia.However both tm monoblock tibias were manufactured, inspected and packaged within established process specifications and each is compatible with either femoral component that was implanted.Insufficient information was available for this investigation which precludes a detailed engineering assessment; therefore, this investigation is considered closed at this time.Should additional information become available, this investigation can be re-opened.

Event Description

Pain - no revision.

• Brand Name: TM CR MONOBLOCK TIBIAL COMPONENT
• 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: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 5473885
• MDR Text Key: 39459715
• Report Number: 3005751028-2016-00013
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

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
• Device Expiration Date: 09/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 00588604412
• Device Lot Number: 61053893
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2008
• 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): Other