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

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5; g3; h2; upon further review, it is noted the patient experienced a blister.Blisters are a fluid filled sac located under the top layer of the skin.These result due to heat or friction at the site and most often resolve on their own.Reviewing the office note provided, the doctor does not mention an intervention and states he expects the blister to resolve on its own.As a blister is a mild injury and no intervention is noted, this would not be considered a serious injury or reportable.The initial report was forwarded in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Upon further review, it is noted the patient experienced a blister.Blisters are a fluid filled sac located under the top layer of the skin.These result due to heat or friction at the site and most often resolve on their own.Reviewing the office note provided, the doctor does not mention an intervention and states he expects the blister to resolve on its own.As a blister is a mild injury and no intervention is noted, this would not be considered a serious injury or reportable.

• Brand Name: ROSA KNEE PLATFORM US PL B
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• MDR Report Key: 11848036
• MDR Text Key: 251399358
• Report Number: 0009617840-2021-00004
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• 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 Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 93