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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE D 8 MM THICKNESS PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE D 8 MM THICKNESS PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Associated products: unknown, persona tibial tray. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the doctor tried to lock poly into tray and it did not seat. The tibial tray stayed implanted in patient. No surgical delay as there was a back up device available. No impact to patient.

 
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Brand NamePARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE D 8 MM THICKNESS
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 Key9418154
MDR Text Key189995070
Report Number0001822565-2019-05159
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK161592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42528200408
Device LOT Number64090043
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 Received01/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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