MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TALAR COMPONENT; PROSTHESIS, EXTREMITIES

Catalog Number UNKNOWN TALAR COMPONENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02810.0001822565-2020-02811.Study was conducted between (b)(6) 2013 and (b)(6) 2016.Concomitant medical products: item# unknown tibial base component; lot# unknown.Item# unknown tibial insert component; lot# unknown.(b)(6).Foreign report source: (b)(6).Literature - retrieved from: maccario c, tan ew, silvestri cad, indino c, kang hp, usuelli fg.Learning curve assessment for total ankle replacement using the transfibular approach.Foot and ankle surgery.2020.Doi:10.1016/j.Fas.2020.03.005.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 approximately one (1) week ago, a journal article was retrieved from foot and ankle surgery (2020) that reported a study from italy that looked at the learning curve assessment for total ankle replacement using the transfibular approach.The study reported two patients whom experienced delayed wound healing and received oral antibiotic treatment.

Manufacturer Narrative

No product was returned; visual and dimensional evaluations could not be performed.Insufficient information provided.Unable to perform a compatibility check.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN TALAR COMPONENT
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10363530
• MDR Text Key: 201840664
• Report Number: 0001822565-2020-02809
• Device Sequence Number: 1
• Product Code: HSN
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN TALAR COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention