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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC STEM PROSTHESIS, HIP Back to Search Results
Catalog Number 51-104170
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Impaired Healing (2378)
Event Date 12/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 110010264/ g7 multihole shell / lot # 6506718, item # unk/ unk liner /lot # unk, item# 12-115109/ bioloxd hd/ lot# 2983159. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 - 00522, 0001825034 -2020 -00530.
 
Event Description
It was reported approximately one-month post implantation the patient received medical intervention for stitch abscess. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTAPERLOC STEM
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 Key9685179
MDR Text Key178318904
Report Number0001825034-2020-00523
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number51-104170
Device Lot Number6541698
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 Received05/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2019
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: 02/09/2020 Patient Sequence Number: 1
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