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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT PROSTHESIS, ANKLE

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ZIMMER BIOMET, INC. TALAR COMPONENT ORANGE SIZE 4 RIGHT PROSTHESIS, ANKLE Back to Search Results
Catalog Number 00450002400
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Concomitant medical devices: tm ankle tibial base size 4 cat# 00450004400 lot# 64199805; prolong tibial insert sz 4 +2 cat# 00450005402 lot# 63655806; dist lat fib lck plate 6h rt cat#00-2357-017-06 lot#ni; p scr 3 5mmx14mm w/2 7mm hd st cat# 00-2348-014-35 lot#ni - qty 3; p scr 3 5mmx16mm w/2 7mm hd st cat# 00-2348-016-35 lot#ni - qty 2; 3. 5mm x 16mm locking screw cat# 00-2359-016-35 lot#ni; 3. 5mm x 18mm locking screw cat# 00-2359-018-35 lot#ni; 3. 5mm x 20mm locking screw cat# 00-2359-020-35 lot#ni. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00009, 0001822565-2020-03873.
 
Event Description
It was reported that a patient underwent an unknown ankle procedure. Subsequently, the patient has reported pain and impingement issues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTALAR COMPONENT ORANGE SIZE 4 RIGHT
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 Key11139356
MDR Text Key225746358
Report Number0001822565-2021-00010
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00450002400
Device Lot Number63936458
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 Received04/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/08/2021 Patient Sequence Number: 1
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