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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM GB PL G INSTRUMENT, KNEE

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ZIMMER CAS ROSA KNEE PLATFORM GB PL G INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problems Incorrect Measurement (1383); Output Problem (3005); Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Age: (b)(6). Report source: (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is remains at the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the planned outcome and validated cut showed 0 degrees varus/valgus. However, post-op x-rays show a grade 2 valgus. It was noted that the patient was varus pre-op.
 
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Brand NameROSA KNEE PLATFORM GB PL G
Type of DeviceINSTRUMENT, KNEE
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 Key9632853
MDR Text Key189995556
Report Number0009617840-2020-00001
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K19074
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 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-100-12
Device Lot NumberN/A
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 Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/27/2020 Patient Sequence Number: 1
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