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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Devries et al (2017)."perioperative complications and initial alignment of lateral approach total ankle arthroplasty".The journal of foot and ankle surgery (2017) pg.1-5.Reference journal article attached.Http://dx.Doi.Org/10.1053/j.Jfas.2017.04.016.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Initial reporter - the article was written by j.George devries, todd a.Derkensen, brandon m.Scharer and robert limoni involving hospitals (b)(6).Concomitant devices - unknown trabecular metal total ankle talar component catalog #: ni lot #: ni, unknown trabecular metal total ankle tibial articular surface catalog #: ni lot #: ni.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.This report is number 2 of 3 mdrs filed for the same patient (reference 0001822565-2017-05146 / 05148).

Event Description

It is reported in a journal article that one (1) patient developed a superficial wound complication involving delayed wound healing following ankle arthroplasty.The patient was treated topically.Attempts have been made to retrieve additional information, but no further information is available at this time.

• Brand Name: UNKNOWN TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
• Type of Device: PROSTHESIS, ANKLE
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6740756
• MDR Text Key: 80934115
• Report Number: 0001822565-2017-05147
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2017
• 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