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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 10MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 10MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Pain (1994); Scar Tissue (2060); No Information (3190)
Event Date 10/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown-m2a cup-unknown. Unknown-m2a head-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01745. 0001825034 - 2020 - 01746. Reported event was unable to be confirmed. Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided. 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. Product location unknown.
 
Event Description
It was reported the patient is experiencing unknown issues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTAPERLOC MICRO LAT FMRL 10MM
Type of DevicePROSTHESIS, HIP
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 Key9985823
MDR Text Key188514688
Report Number0001825034-2020-01747
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Model NumberN/A
Device Catalogue Number15-103204
Device Lot Number366380
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 04/22/2020 Patient Sequence Number: 1
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