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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 1 8 MM HEIGHT FEMORAL PROSTHESIS KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 1 8 MM HEIGHT FEMORAL PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Additional concomitant medical products: catalog #: 00584200101, tibial component precoat left medial/right, lot # 63797666; catalog #: 00584201301, femoral component high flex precoat, lot # 63943899. (b)(6). 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. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Will be returned.

 
Event Description

It was reported that it was impossible for surgeon to insert the articular surface into the tibial plate. A same-sized new surface was used to complete the surgery.

 
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Brand NameARTICULAR SURFACE SIZE 1 8 MM HEIGHT FEMORAL
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 Key8355336
MDR Text Key136767409
Report Number0001822565-2019-00747
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00584202108
Device LOT Number63626197
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/01/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/17/2017
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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