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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER CAS ROSA RECON PLATFORM 220V ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  Injury  
Event Description
It was reported that following a tka done by rosa knee surgical instrumentation, femoral notching was noticed in the post operative x-rays. No known impact or consequence to the patient has been reported at this time. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Zimmer biomet - (b)(4). This product is similar to pma/510(k) : k182964. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
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Brand NameROSA RECON PLATFORM 220V
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 Key13417029
MDR Text Key284862663
Report Number0009617840-2022-00009
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-100-26
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2021
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: 02/01/2022 Patient Sequence Number: 1
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