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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT PROSTHESIS, ANKLE

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ZIMMER BIOMET, INC. TALAR COMPONENT PROSTHESIS, ANKLE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Tissue Damage (2104)
Event Date 05/23/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: catalog #: 00830004300, tibial base component size 3, lot # 63342717. Catalog #: 00830005300, tibial insert component size 3, lot # 63414807. Catalog #: 00493500903, one-third tubular plate with collar, lot # 63518815. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019 -03610, 0001822565-2019-03612, 0001822565-2019-03615. Device evaluated by manufacturer? remains implanted.

 
Event Description

It was reported that the patient underwent primary ankle approximately two years ago. Subsequently at the two year visit the patient was experiencing moderate pain, restricted rom, drainage, and was noted to have impingement. A month ago the patient underwent arthroscopic & debridement procedure, the implant remains implanted.

 
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Brand NameTALAR COMPONENT
Type of DevicePROSTHESIS, ANKLE
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 Key8954084
MDR Text Key156260504
Report Number0001822565-2019-03611
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00830002300
Device LOT Number62946236
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 Received10/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/23/2015
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: 09/02/2019 Patient Sequence Number: 1
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