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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 11 MM THICKNESS PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 11 MM THICKNESS PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05607 and 0001825034-2019-05787. Concomitant medical products: unknown persona partial knee femoral: catalog#: ni, lot#: ni. Unknown persona partial knee tibial tray: catalog#: ni, lot#: ni. 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 during a knee procedure, the tibial insert would not seat on the tibial tray. The procedure was completed using another tibial insert. No adverse events have been reported as a result of the malfunction.

 
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Brand NamePARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE F 11 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 Key9532285
MDR Text Key201854554
Report Number0001825034-2019-05607
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42518200611
Device LOT Number64157510
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2018
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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