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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM US PL B ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER CAS ROSA KNEE PLATFORM US PL B ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Output Problem (3005)
Patient Problem No Code Available (3191)
Event Date 09/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). An investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Hospital owns the product.
 
Event Description
It was reported that femoral notching occurred during a robotic assisted total knee arthroplasty. No additional patient injury was reported.
 
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Brand NameROSA KNEE PLATFORM US PL B
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer (Section G)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10778568
MDR Text Key214791562
Report Number0009617840-2020-00006
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-100-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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