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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN ZIMMER ANKLE FIBULAR PLATE PROSTHESIS, ANKLE Back to Search Results
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.

 
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Brand NameUNKNOWN ZIMMER ANKLE FIBULAR PLATE
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 Key6740355
MDR Text Key80918820
Report Number0001822565-2017-05143
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
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