MAUDE Adverse Event Report: ZIMMER TMT TM-S FUSION DEVICE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 07/15/2016

Event Type  Injury  

Manufacturer Narrative

Investigation in process.

Event Description

It was reported that the patient was revised due to pain.No other details are known at this time.

Manufacturer Narrative

The implant surgery occurred on (b)(6) 2012 at (b)(6).After approximately five years, pseudo-arthrosis was diagnosed as a symptomatic issue.The patient also experienced modic changes, which led to continuous pain and ultimately, a revision surgery on (b)(6) 2016.The revision surgery involved removing the standalone tm-s device and implanting a new tm-s, 7mm in height (part no.06-101-03071, lot no.63138197), with a supplemental fixation system of four screws and a base plate.There was no harm or delay in surgery.The removed tm-s implant was returned and a visual inspection was made.Material within the graft hole was identified, but the material composition could not be confirmed.The x-rays were analyzed and the observations could not be directly linked to any issues.Since the device¿s lot number could not be retrieved, the dhr could not be reviewed.Causation between pseudo-arthrosis and pain-causing modic changes cannot be definitely concluded.No further action is necessary at this time.

Event Description

Revision due to pain.

• Brand Name: TM-S FUSION DEVICE
• Type of Device: TM-S
• 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: 5818633
• MDR Text Key: 50304855
• Report Number: 3005751028-2016-00057
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK111119
• 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,Followup
• Report Date: 07/20/2016

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 Model Number: N/A
• Device Catalogue Number: 0610103041
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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