MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TM ANKLE TIBIA COMPONENT; TRAUMA, PROSTHESIS

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Jie chen, md, mph, craig c.Akoh, md, rishin kadakia, md, jeremy s.Somerson, md, mark e.Easley, md, samuel b.Adams, md, james k.Deorio, md, and james a.Nunley, m.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported in a journal article from foot & ankle specialists that reported a us study of adverse events, that five patients had tibia loosening / subsidence.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

These events were addressed in (b)(4) , and(b)(4).A maude extract for the specified time period (b)(6)2015 -(b)(6)2018 was compared against a complaint pull, and all events were addressed within the aforementioned complaints.It can be deduced that the other complications were for other competitive systems.The initial report was forwarded in error and should be voided.

Event Description

These events were addressed in (b)(4), and(b)(4).A maude extract for the specified time period (b)(6)2015 -(b)(6)2018 was compared against a complaint pull, and all events were addressed within the aforementioned complaints.It can be deduced that the other complications were for other competitive systems.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN TM ANKLE TIBIA COMPONENT
• Type of Device: TRAUMA, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10356162
• MDR Text Key: 201506594
• Report Number: 0001822565-2020-02732
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other