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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Unspecified Infection (1930)
Event Date 01/31/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 42502606801, femur cemented cruciate retaining (cr) standard left size 10, lot #: 64284726. 42532007501, tibia cemented 5 degree stemmed left size f, lot #: ni. Report source: event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00064, 0001822565 - 2020 - 00709.

 
Event Description

It was reported that approximately 3 months post implantation, the patient was revised due to infection of the left knee. Attempts have been made and no further information has been provided.

 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 10 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 Key9753767
MDR Text Key182701993
Report Number3007963827-2020-00065
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberK150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42512100810
Device LOT Number63982446
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/10/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/26/2020 Patient Sequence Number: 1
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