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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 12 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 12 MM HEIGHT 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 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown femoral component, unknown tibial tray. Report source: foreign country: (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.
 
Event Description
It was reported the bearing would not assemble with the tibial tray. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 12 MM HEIGHT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9777688
MDR Text Key191580572
Report Number3007963827-2020-00068
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K121771
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 04/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42511200612
Device Lot Number64416906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2019
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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