MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT; ANKLE PROSTHESIS

Catalog Number 00450002400

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experienced heterotrophic ossification anterior to the ankle post op.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.Design history records review indicates that all devices from the lot were manufactured to specifications for both tibial base and talar component.This device is used for treatment.Initial product history search revealed no additional complaints against the related part and lot combination for both tibial base and talar component.It is noted in op-notes that patient had history of prior fracture of his ankle requiring surgical open reduction internal fixation.A definite root cause cannot be determined with the information provided.This report is number 2 of 2 mdrs filed for the same event (reference 1822565-2016-03261-1 and 1822565-2016-03262-1).

Manufacturer Narrative

This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported the patient was revised to address pain/discomfort, weakness, swelling, stiffness, mobility, tenderness, and patient fall.No further information has been made available.

Manufacturer Narrative

Reported event was confirmed by review of x-rays provided.Physician assessment of radiographs indicated heterotopic ossification anterior to joint at 3 months and 1 year.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5949333
• MDR Text Key: 54670059
• Report Number: 0001822565-2016-03262
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120906
• 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,Followup,Followup
• Report Date: 03/06/2018

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: 11/30/2023
• Device Catalogue Number: 00450002400
• Device Lot Number: 62486259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided; 10/10/2017; 03/06/2018
• Supplement Dates FDA Received: 01/17/2017; 11/08/2017; 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• 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
• Patient Age: 62 YR
• Patient Weight: 100