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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR PROSTHESIS HIP

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ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR PROSTHESIS HIP Back to Search Results
Catalog Number 15-105044
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: item # 15-103684/ m2a-t univ 2-hole shl/ lot # 380410; item # 11-163688/ 32mm m2a hi carbon hd std/ lot # 985970; item # 103533/ low profile screw / lot # 306820; item # 103530/ low profile screw / lot # 21. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00938, 0001825034 -2021 -00939.
 
Event Description
It was reported that patient underwent right hip revision surgery 16 years post implantation for unknown reasons. The head, shell, and liner were revised. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A TPR HI CARBON 41/32MM LNR
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 Key11595248
MDR Text Key243338625
Report Number0001825034-2021-00937
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/17/2017
Device Catalogue Number15-105044
Device Lot Number111150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2007
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: 03/31/2021 Patient Sequence Number: 1
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