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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 Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2021
Event Type  Injury  
Event Description
It was reported that a patient underwent a robotic assisted tka surgery and the cuts performed on the tibial resections were around 4-4. 5 mm off (overcut) from planned resection values. The procedure was completed using a larger poly (14mm) than planned (10mm) with no known reported impact to the patient. Patient was pain free and discharged 3 days post op. It was reported that no additional information is available regarding this incident.
 
Manufacturer Narrative
Zimmer biomet complaint: (b)(4). This product is same or similar to pma/510(k) number: k182964. Country of origin: (b)(6). This event was previously submitted on nov 8th under mfr report: 0001822565-2021-03207. The event is being resubmitted under this initial report to correct the mfr number and corresponding manufacturing information. Updated fields from mfr: 0001822565-2021-03207. Country of origin: (b)(6). All necessary information needed for the investigation has been provided and an investigation is in process. Once the investigation has been completed, a follow-up mdr 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 Key13994709
MDR Text Key288481678
Report Number0009617840-2022-00016
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
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 Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
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: 04/04/2022 Patient Sequence Number: 1
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