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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN CONST TASP SHIM GH 12MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PSN CONST TASP SHIM GH 12MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04235, 0001822565-2019-04282, 0001822565-2019-04283.
 
Event Description
It was reported that the tibial articulation surface provisional shims were returned as worn and missing ball bearing. No additional information is available.
 
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Brand NamePSN CONST TASP SHIM GH 12MM
Type of DevicePROSTHESIS, KNEE
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 Key9152386
MDR Text Key164271383
Report Number0001822565-2019-04281
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42527900602
Device Lot Number62967513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-1052-2015

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