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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS ROSA PERSONA TKA CUT GUIDE A ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER CAS ROSA PERSONA TKA CUT GUIDE A 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 09/13/2021
Event Type  malfunction  
Event Description
It was reported that a patient underwent a tka surgery and the cuts performed on the tibia and femur resections were 3mm off (overcut) from planned resection values. The procedure was completed using a larger poly with no known impact or consequence to the patient. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand NameROSA PERSONA TKA CUT GUIDE A
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 Key12624672
MDR Text Key281079974
Report Number0009617840-2021-00022
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-007-00
Device Lot NumberJ190690
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2020
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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