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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN EXTREMITY HARDWARE PROSTHESIS, EXTREMITIES

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ZIMMER BIOMET, INC. UNKNOWN EXTREMITY HARDWARE PROSTHESIS, EXTREMITIES Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical devices: unknown extremity hardware. Foreign: event occurred in (b)(6). The product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02701. Reference: camilla maccario, eric w. Tan, claudia angela di silvestri, cristian indino, h. Paco kang & federico giuseppe usuelli (2020). Learning curve assessment for total ankle replacement using the transfibular approach. Foot and ankle surgery. Https://doi. Org/10. 1016/j. Fas. 2020. 03. 005. Remains implanted.

 
Event Description

It was reported in a journal article that six patients underwent a total ankle replacement surgery on an unknown date. Subsequently, patients developed symptomatic fibular hardware. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameUNKNOWN EXTREMITY HARDWARE
Type of DevicePROSTHESIS, EXTREMITIES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10378482
MDR Text Key202013318
Report Number0001822565-2020-02645
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2020
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: 08/07/2020 Patient Sequence Number: 1
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