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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the instrument fractured during surgery. There was no harm to the patient. Attempts have been made and no further information has been provided.
 
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Brand NameTIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH
Type of DeviceINSTRUMENT, 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 Key9196415
MDR Text Key190006254
Report Number0001822565-2019-04453
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42517000707
Device Lot Number63563286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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