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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
Zimmer biomet complaint (b)(4). This incident was deemed reportable for device malfunction after the investigation results were made available to complaint handler on 16-nov-2021. Rosa camera accuracy verified from the investigation log files. All setup steps for rosa surgery occurred without issue. Onsite representative reported reported by email that the cut guide was not positioned in the same position relative to the bone as in the first cut on the tibial resection. This information indicated a movement of the bone navitracker relative to the cut guide. This suggest a retractor was put in place after pinning cut guide instead of before as recommended by surgical technique. Review of the dhr for p/n 20-8020-100-01, s/n (b)(4) (rosa recon platform us pl b) identified no deviation and/or anomalies related to the reported complaint event. A definitive root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that during a tka rosa cut validations were off from planned tibial values by 4mm on medial and lateral sides. Upon completion of the investigation into this incident and reassessment of the complaint it was determined that over resection of 4mm had occurred on tibia. The procedure was completed with no known impact or consequence to the patient. Attempts have been made and no further information has been provided.
 
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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 BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12984829
MDR Text Key282126108
Report Number0001822565-2021-03500
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-100-01
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 Received06/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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