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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE PLATFORM US PL B PROSTHESIS, KNEE

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ZIMMER CAS ROSA KNEE PLATFORM US PL B PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products: 42500006402-femur cemented posterior stabilized (ps) narrow right size 8-64792669. 42532007102-tibia cemented 5 degree stemmed right size e- 64786783. 42522400710-articular surface fixed bearing posterior stabilized (ps) right 10 mm height-64667057. 42540000035-all poly patella cemented 35 mm diameter-64830162. Product will not be returned to zimmer biomet for investigation, rosa robots are worked on at location. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Rosa robots are work on at the location.
 
Event Description
It was reported the patient underwent an initial right total knee arthroplasty under rosa guidance. Subsequently during the procedure, the patient formed a large blister on the right tibia from rosa. This was treated with observation only and no additional intervention. The patient was discharged home without complication. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameROSA KNEE PLATFORM US PL B
Type of DevicePROSTHESIS, 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 Key11848036
MDR Text Key251399358
Report Number0009617840-2021-00004
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number20-8020-100-01
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 05/19/2021 Patient Sequence Number: 1
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