MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER ANKLE FIBULAR PLATE; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(6) 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.(b)(6).The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.(b)(4).

Event Description

It is reported in a journal article that three (3) patients experienced delayed or nonunion of the fibula following ankle arthroplasty, and were treated with an external bone stimulator.Attempts have been made to retrieve additional information, but no further information is available at this time.

• Brand Name: UNKNOWN ZIMMER ANKLE FIBULAR PLATE
• 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: 6740355
• MDR Text Key: 80918820
• Report Number: 0001822565-2017-05143
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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