• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER, INC. UNKNOWN TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT PROSTHESIS, ANKLE Back to Search Results
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 baycare clinic, green bay, wisconsin and orthopedics and sports institute of the fox valley, appleton, wisconsin. Concomitant devices - unknown trabecular metal total ankle tibial base 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 1 of 3 mdrs filed for the same patient (reference 0001822565-2017-05147 / 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
Type of DevicePROSTHESIS, 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 Key6740386
MDR Text Key80924651
Report Number0001822565-2017-05146
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received07/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2017
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 NumberN/A

Patient TREATMENT DATA
Date Received: 07/25/2017 Patient Sequence Number: 1
-
-