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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 2 9 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE 2 9 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source - (b)(6). Customer has indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that during the operation of zuk single condyle replacement, the surgeon performed the osteotomy according to the technical requirements. However, when opening the articular surface, the implant could not be implanted normally. After the attempt, the implant could not be implanted, so the surgeon had to open a box of new implants of the same type again to complete the operation. There is no additional information available at this time.

 
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Brand NameARTICULAR SURFACE SIZE 2 9 MM HEIGHT
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 Key10148478
MDR Text Key194967494
Report Number0001822565-2020-02071
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK033363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00584202209
Device LOT Number63975407
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2018
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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